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BPHARMA

The document outlines the syllabus for the B. Pharma program at Veer Madho Singh Bhandari Uttarakhand Technical University for the 2023-24 academic session. It includes detailed course content for various subjects such as Pharmaceutical Organic Chemistry, Physical Pharmaceutics, and Pharmaceutical Microbiology, along with evaluation patterns and practical components. The syllabus was approved in March 2023 and is aimed at students admitted in the 2022-23 academic year and onwards.

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NISHANT CHAUHAN
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© © All Rights Reserved
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0% found this document useful (0 votes)
109 views122 pages

BPHARMA

The document outlines the syllabus for the B. Pharma program at Veer Madho Singh Bhandari Uttarakhand Technical University for the 2023-24 academic session. It includes detailed course content for various subjects such as Pharmaceutical Organic Chemistry, Physical Pharmaceutics, and Pharmaceutical Microbiology, along with evaluation patterns and practical components. The syllabus was approved in March 2023 and is aimed at students admitted in the 2022-23 academic year and onwards.

Uploaded by

NISHANT CHAUHAN
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICAL UNIVERSITY

(Formerly Uttarakhand Technical University, Dehradun Established by Uttarakhand State Govt. wide Act no. 415 of 2005)
Suddhowala, PO-Chandanwadi, Premnagar, Dehradun, Uttarakhand (Website- [Link])

SYLLABUS
Approved in 13th Meeting of Executive Council held
on 27th March 2023 subsequent to the 14th Meeting
of Academic Council held on 20th March 2023

(For admission in 2022-23 and onwards)


VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY


(Formerly Uttarakhand Technical University, Dehradun Established by Uttarakhand State Govt. wide Act no. 415 of 2005)
Suddhowala, PO-Chandanwadi, Premnagar, Dehradun, Uttarakhand (Website- [Link])

SYLLABUS
For

B. PHARMA
2ND Year (III SEMESTER)

Effective From – Session 2023-24

Syllabus of [Link]
1
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

SEMESTER III

Evaluation pattern

Syllabus of [Link]
2
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP301T. PHARMACEUTICAL ORGANIC CHEMISTRY –II (Theory)


45 Hours
Scope: This subject deals with general methods of preparation and reactions of some
organic compounds. Reactivity of organic compounds are also studied here. The syllabus
emphasizes on mechanisms and orientation of reactions. Chemistry of fats and oils are also
included in the syllabus.
Objectives: Upon completion of the course the student shall be able to
1. write the structure, name and the type of isomerism of the organic compound
2. write the reaction, name the reaction and orientation of reactions
3. account for reactivity/stability of compounds,
4. prepare organic compounds

Course Content:
General methods of preparation and reactions of compounds superscripted with asterisk (*) to be
explained
To emphasize on definition, types, classification, principles/mechanisms, applications, examples
and differences
UNIT I 10 Hours
• Benzene and its derivatives
A. Analytical, synthetic and other evidences in the derivation of structure
of benzene, Orbital picture, resonance in benzene, aromatic characters,
Huckel’s rule
B. Reactions of benzene - nitration, sulphonation, halogenation- reactivity,
Friedelcrafts alkylation- reactivity, limitations, Friedelcrafts acylation.
C. Substituents, effect of substituents on reactivity and orientation of mono
substituted benzene compounds towards electrophilic substitution
reaction
D. Structure and uses of DDT, Saccharin, BHC and Chloramine
UNIT II 10 Hours
• Phenols* - Acidity of phenols, effect of substituents on acidity, qualitative
tests, Structure and uses of phenol, cresols, resorcinol, naphthols
• Aromatic Amines* - Basicity of amines, effect of substituents on basicity,
and synthetic uses of aryl diazonium salts
• Aromatic Acids* –Acidity, effect of substituents on acidity and
important reactions of benzoic acid.

Syllabus of [Link]
3
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

UNIT III
10 Hours
• Fats and Oils
a. Fatty acids – reactions.
b. Hydrolysis, Hydrogenation, Saponification and Rancidity of oils, Drying
oils.
c. Analytical constants – Acid value, Saponification value, Ester value, Iodine
value, Acetyl value, Reichert Meissl (RM) value – significance and principle
involved in their determination.
UNIT IV 08 Hours
• Polynuclear hydrocarbons:
a. Synthesis, reactions
b. Structure and medicinal uses of Naphthalene, Phenanthrene, Anthracene,
Diphenylmethane, Triphenylmethane and their derivatives
UNIT V 07 Hours
• Cyclo alkanes*
Stabilities – Baeyer’s strain theory, limitation of Baeyer’s strain theory,
Coulson and Moffitt’s modification, Sachse Mohr’s theory (Theory of
strainless rings), reactions of cyclopropane and cyclobutane only

Syllabus of [Link]
4
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP305P. PHARMACEUTICAL ORGANIC CHEMISTRY -II (Practical)


4 Hrs/week

I Experiments involving laboratory techniques


• Recrystallization
• Steam distillation

II Determination of following oil values (including standardization of


reagents)
• Acid value
• Saponification value
• Iodine value

III Preparation of compounds


• Benzanilide/Phenyl benzoate/Acetanilide from Aniline/ Phenol
/Aniline by acylation reaction.
• 2,4,6-Tribromo aniline/Para bromo acetanilide from Aniline/
• Acetanilide by halogenation (Bromination) reaction.
• 5-Nitro salicylic acid/Meta di nitro benzene from Salicylic acid /
Nitro benzene by nitration reaction.
• Benzoic acid from Benzyl chloride by oxidation reaction.
• Benzoic acid/ Salicylic acid from alkyl benzoate/ alkyl salicylate by
hydrolysis reaction.
• 1-Phenyl azo-2-napthol from Aniline by diazotization and coupling
reactions.
• Benzil from Benzoin by oxidation reaction.
• Dibenzal acetone from Benzaldehyde by Claison Schmidt reaction
• Cinnammic acid from Benzaldehyde by Perkin reaction
• P-Iodo benzoic acid from P-amino benzoic acid

Recommended Books (Latest Editions)


1. Organic Chemistry by Morrison and Boyd
2. Organic Chemistry by I.L. Finar , Volume-I
3. Textbook of Organic Chemistry by B.S. Bahl & Arun Bahl.
4. Organic Chemistry by [Link]

Syllabus of [Link]
5
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

5. Practical Organic Chemistry by Mann and Saunders.


6. Vogel’s text book of Practical Organic Chemistry
7. Advanced Practical organic chemistry by [Link].
8. Introduction to Organic Laboratory techniques by Pavia, Lampman and Kriz.

Syllabus of [Link]
6
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP302T. PHYSICAL PHARMACEUTICS-I (Theory)


45Hours

Scope: The course deals with the various physica and physicochemical properties, and
principles involved in dosage forms/formulations. Theory and practical
components of the subject help the student to get a better insight into various areas
of formulation research and development, and stability studies of pharmaceutical
dosage forms.

Objectives: Upon the completion of the course student shall be able to


1. Understand various physicochemical properties of drug molecules in the
designing the dosage forms
2. Know the principles of chemical kinetics & to use them for stability testing nad
determination of expiry date of formulations
3. Demonstrate use of physicochemical properties in the formulation
development and evaluation of dosage forms.

Course Content:
UNIT-I 10 Hours

Solubility of drugs: Solubility expressions, mechanisms of solute solvent interactions,


ideal solubility parameters, solvation & association, quantitative approach to the factors
influencing solubility of drugs, diffusion principles in biological systems. Solubility
of gas in liquids, solubility of liquids in liquids, (Binary solutions, ideal solutions)
Raoult’s law, real solutions. Partially miscible liquids, Critical solution temperature and
applications. Distribution law, its limitations and applications

UNIT-II 10Hours

States of Matter and properties of matter:State of matter, changes in the state of matter,
latent heats, vapour pressure, sublimation critical point, eutectic mixtures, gases, aerosols
– inhalers, relative humidity, liquid complexes, liquid crystals, glassy states, solid-
crystalline, amorphous & polymorphism.

Physicochemical properties of drug molecules: Refractive index, optical rotation,


dielectric constant, dipole moment, dissociation constant, determinations and applications

UNIT-III 08 Hours

Surface and interfacial phenomenon: Liquid interface, surface & interfacial tensions,

surface free energy, measurement of surface & interfacial tensions, spreading coefficient,
adsorption at liquid interfaces, surface active agents, HLB Scale, solubilisation,detergency,
adsorption at solid interface.
Syllabus of [Link]
7
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

UNIT-IV 08Hours

Complexation and protein binding: Introduction, Classification of Complexation,


Applications, methods of analysis, protein binding, Complexation and drug action,
crystalline structures of complexes and thermodynamic treatment of stability constants.

UNIT-V 07 Hours

pH, buffers and Isotonic solutions: Sorensen’s pH scale, pH determination (electrometric


and calorimetric), applications of buffers, buffer equation, buffer capacity, buffers in
pharmaceutical and biological systems, buffered isotonic solutions.

Syllabus of [Link]
[Type text] [Type text] [Type text]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP306P. PHYSICAL PHARMACEUTICS – I (Practical)


4 Hrs/week
1. Determination the solubility of drug at room temperature

2. Determination of pKa value by Half Neutralization/ Henderson Hasselbalch


equation.
3. Determination of Partition co- efficient of benzoic acid in benzene and water
4. Determination of Partition co- efficient of Iodine in CCl4 and water
5. Determination of % composition of NaCl in a solution using phenol-water system by
CST method
6. Determination of surface tension of given liquids by drop count and drop weight
method
7. Determination of HLB number of a surfactant by saponification method
8. Determination of Freundlich and Langmuir constants using activated char coal
9. Determination of critical micellar concentration of surfactants
10. Determination of stability constant and donor acceptor ratio of PABA-Caffeine
complex by solubility method
11. Determination of stability constant and donor acceptor ratio of Cupric-Glycine
complex by pH titration method

Recommended Books: (Latest Editions)

1. Physical Pharmacy by Alfred Martin


2. Experimental Pharmaceutics by Eugene, Parott.
3. Tutorial Pharmacy by Cooper and Gunn.
4. Stocklosam J. Pharmaceutical Calculations, Lea &Febiger, Philadelphia.
5. Liberman H.A, Lachman C., Pharmaceutical Dosage forms, Tablets, Volume-1 to
3, MarcelDekkar Inc.
6. Liberman H.A, Lachman C, Pharmaceutical Dosage forms. Disperse
systems, volume 1, 2, 3. Marcel Dekkar Inc.
7. Physical Pharmaceutics by Ramasamy C and ManavalanR.
8. Laboratory Manual of Physical Pharmaceutics, C.V.S. Subramanyam, J.
Thimma settee
9. Physical Pharmaceutics by C.V.S. Subramanyam
10. Test book of Physical Phramacy, by Gaurav Jain & Roop K. Khar

Syllabus of [Link] 9
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 303 T. PHARMACEUTICAL MICROBIOLOGY (Theory)

45Hours
Scope:

• Study of all categories of microorganisims especially for the production of alchol


antibiotics, vaccines, vitamins enzymes etc..

Objectives: Upon completion of the subject student shall be able to;


1. Understand methods of identification, cultivation and preservation of
various microorganisms
2. To understand the importance and implementation of sterlization in
pharmaceutical processing and industry
3. Learn sterility testing of pharmaceutical products.
4. Carried out microbiological standardization of Pharmaceuticals.
5. Understand the cell culture technology and its applications in pharmaceutical
industries.

Course content:

Unit I 10 Hours
Introduction, history of microbiology, its branches, scope and its importance.
Introduction to Prokaryotes and Eukaryotes
Study of ultra-structure and morphological classification of bacteria,
nutritional requirements, raw materials used for culture media and physical
parameters for growth, growth curve, isolation and preservation methods for
pure cultures, cultivation of anaerobes, quantitative measurement ofbacterial
growth (total & viable count).
Study of different types of phase constrast microscopy, dark field
microscopy and electron microscopy.
Unit II 10 Hours

Identification of bacteria using staining techniques (simple, Gram’s &Acid


fast staining) and biochemical tests (IMViC).
Study of principle, procedure, merits, demerits and applications of physical,
chemical gaseous,radiation and mechanical method of sterilization.
Evaluation of the efficiency of sterilization methods.

Syllabus of [Link] 10
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Equipments employed in large scale sterilization.


Sterility indicators.

Unit III 10 Hours

Study of morphology, classification, reproduction/replication and


cultivation of Fungi and Viruses.
Classification and mode of action of disinfectants
Factors influencing disinfection, antiseptics and their evaluation. For
bacteriostatic and bactericidal actions
Evaluation of bactericidal & Bacteriostatic.
Sterility testing of products (solids, liquids, ophthalmic and other sterile
products) according to IP, BP and USP.

Unit IV 08 Hours
Designing of aseptic area, laminar flow equipments; study of different sources
of contamination in an aseptic area and methods of prevention, clean area
classification.
Principles and methods of different microbiological assay. Methods for
standardization of antibiotics, vitamins and amino acids.
Assessment of a new antibiotic.
Unit V 07Hours

Types of spoilage, factors affecting the microbial spoilage of pharmaceutical


products, sources and types of microbial contaminants, assessment of
microbial contamination and spoilage.
Preservation of pharmaceutical products using antimicrobial agents,
evaluation of microbial stability of formulations.
Growth of animal cells in culture, general procedure for cell culture,
Primary, established and transformed cell cultures.
Application of cell cultures in pharmaceutical industry and research.

Syllabus of [Link] 11
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP [Link] MICROBIOLOGY (Practical)


4 Hrs/week

1. Introduction and study of different equipments and processing, e.g., B.O.D. incubator,
laminar flow, aseptic hood, autoclave, hot air sterilizer, deep freezer, refrigerator,
microscopes used in experimental microbiology.
2. Sterilization of glassware, preparation and sterilization of media.
3. Sub culturing of bacteria and fungus. Nutrient stabs and slants preparations.
4. Staining methods- Simple, Grams staining and acid fast staining (Demonstration with
practical).
5. Isolation of pure culture of micro-organisms by multiple streak plate technique and other
techniques.
6. Microbiological assay of antibiotics by cup plate method and other methods
7. Motility determination by Hanging drop method.
8. Sterility testing of pharmaceuticals.
9. Bacteriological analysis of water
10. Biochemical test.

Recommended Books (Latest edition)

1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific


publications, Oxford London.
2. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers & Distributors,
Delhi.
3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.
4. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.
5. Rose: Industrial Microbiology.
6. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan
7. Cooper and Gunn’s: Tutorial Pharmacy, CBS Publisher and Distribution.
8. Peppler: Microbial Technology.
9. I.P., B.P., U.S.P.- latest editions.
10. Ananthnarayan : Text Book of Microbiology, Orient-Longman, Chennai
11. Edward: Fundamentals of Microbiology.
12. [Link]: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi
13. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly company

Syllabus of [Link] 12
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 304 T. PHARMACEUTICAL ENGINEERING (Theory)


45 Hours
Scope: This course is designed to impart a fundamental knowledge on the art and science
of various unit operations used in pharmaceutical industry.
Objectives: Upon completion of the course student shall be able:
1. To know various unit operations used in Pharmaceutical industries.
2. To understand the material handling techniques.
3. To perform various processes involved in pharmaceutical manufacturing process.
4. To carry out various test to prevent environmental pollution.
5. To appreciate and comprehend significance of plant lay out design for optimum
use of resources.
6. To appreciate the various preventive methods used for corrosion control in
Pharmaceutical industries.
Course content:

UNIT-I 10 Hours
• Flow of fluids: Types of manometers, Reynolds number and its significance,
Bernoulli’s theorem and its applications, Energy losses, Orifice meter,
Venturimeter, Pitot tube and Rotometer.
• Size Reduction: Objectives, Mechanisms & Laws governing size reduction, factors
affecting size reduction, principles, construction, working, uses, merits and demerits
of Hammer mill, ball mill, fluid energy mill, Edge runner mill & end runner mill.
• Size Separation: Objectives, applications & mechanism of size separation, official
standards of powders, sieves, size separation Principles, construction, working, uses,
merits and demerits of Sieve shaker, cyclone separator, Airseparator, Bag filter &
elutriation tank.

UNIT-II 10 Hours

• Heat Transfer: Objectives, applications & Heat transfer mechanisms. Fourier’s


law, Heat transfer by conduction, convection & radiation. Heat interchangers & heat
exchangers.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

• Evaporation: Objectives, applications and factors influencing evaporation,


differences between evaporation and other heat process. principles, construction,
working, uses, merits and demerits of Steam jacketed kettle, horizontal tube
evaporator, climbing film evaporator, forced circulation evaporator, multiple effect
evaporator& Economy of multiple effect evaporator.

• Distillation: Basic Principles and methodology of simple distillation,flash


distillation, fractional distillation, distillation under reduced pressure, steam
distillation & molecular distillation

UNIT- III 08 Hours


• Drying: Objectives, applications & mechanism of drying process, measurements &
applications of Equilibrium Moisture content, rate of drying curve. principles,
construction, working, uses, merits and demerits of Tray dryer, drum dryer spray
dryer, fluidized bed dryer, vacuum dryer, freeze dryer.

• Mixing: Objectives, applications & factors affecting mixing, Difference between


solid and liquid mixing, mechanism of solid mixing, liquids mixing and semisolids
mixing. Principles, Construction, Working, uses, Merits and Demeritsof Double
cone blender, twin shell blender, ribbon blender, Sigma blade mixer, planetary
mixers, Propellers, Turbines, Paddles & Silverson Emulsifier,

UNIT-IV 08 Hours
• Filtration: Objectives, applications, Theories & Factors influencing filtration, filter
aids, filter medias. Principle, Construction, Working, Uses, Merits and demerits of
plate & frame filter, filter leaf, rotary drum filter, Meta filter & Cartridge filter,
membrane filters and Seidtz filter.
• Centrifugation: Objectives, principle & applications of Centrifugation,principles,
construction, working, uses, merits and demerits of Perforated basket centrifuge,
Non-perforated basket centrifuge, semi continuous centrifuge & super centrifuge.
UNIT- V 07 Hours

• Materials of pharmaceutical plant construction, Corrosion and its prevention:


Factors affecting during materials selected for Pharmaceutical plant construction,
Theories of corrosion, types of corrosion and there prevention. Ferrous and
nonferrous metals, inorganic and organic non metals, basic of material handling
systems.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Recommended Books: (Latest Editions)


1. Introduction to chemical engineering – Walter L Badger & Julius Banchero, Latest
edition.
2. Solid phase extraction, Principles, techniques and applications by Nigel J.K. Simpson-
Latest edition.
3. Unit operation of chemical engineering – Mcabe Smith, Latest edition.
4. Pharmaceutical engineering principles and practices – C.V.S Subrahmanyam et al., Latest
edition.
5. Remington practice of pharmacy- Martin, Latest edition.
6. Theory and practice of industrial pharmacy by Lachmann., Latest edition.
7. Physical pharmaceutics- C.V.S Subrahmanyam et al., Latest edition.
8. Cooper and Gunn’s Tutorial pharmacy, S.J. Carter, Latest edition.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP308P - PHARMACEUTICAL ENGINEERING (Practical)

4 Hours/week

I. Determination of radiation constant of brass, iron, unpainted and painted glass.


II. Steam distillation – To calculate the efficiency of steam distillation.
III. To determine the overall heat transfer coefficient by heat exchanger.
IV. Construction of drying curves (for calcium carbonate and starch).
V. Determination of moisture content and loss on drying.
VI. Determination of humidity of air – i) From wet and dry bulb temperatures –use of
Dew point method.
VII. Description of Construction working and application of Pharmaceutical Machinery
such as rotary tablet machine, fluidized bed coater, fluid energy mill, de
humidifier.
VIII. Size analysis by sieving – To evaluate size distribution of tablet granulations –
Construction of various size frequency curves including arithmetic
andlogarithmic probability plots.
IX. Size reduction: To verify the laws of size reduction using ball mill and determining
Kicks, Rittinger’s, Bond’s coefficients, power requirement and critical speed of
Ball Mill.
X. Demonstration of colloid mill, planetary mixer, fluidized bed dryer, freeze dryer and
such othermajor equipment.
XI. Factors affecting Rate of Filtration and Evaporation (Surface area, Concentration
and Thickness/ viscosity
XII. To study the effect of time on the Rate of Crystallization.
XIII. To calculate the uniformity Index for given sample by using Double Cone
Blender.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY


(Formerly Uttarakhand Technical University, Dehradun Established by Uttarakhand State Govt. wide Act no. 415 of 2005)
Suddhowala, PO-Chandanwadi, Premnagar, Dehradun, Uttarakhand (Website- [Link])

SYLLABUS
For

B. PHARMA
2ND Year (IV SEMESTER)

Effective From – Session 2023-24

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

SEMESTER IV

Evaluation pattern

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP401T. PHARMACEUTICAL ORGANIC CHEMISTRY –III (Theory)


45 Hours
Scope: This subject imparts knowledge on stereo-chemical aspects of organic compounds
and organic reactions, important named reactions, chemistry of important hetero cyclic
compounds. It also emphasizes on medicinal and other uses of organic compounds.
Objectives: At the end of the course, the student shall be able to
1. understand the methods of preparation and properties of organic compounds
2. explain the stereo chemical aspects of organic compounds and stereo chemical
reactions
3. know the medicinal uses and other applications of organic compounds
Course Content:

Note: To emphasize on definition, types, mechanisms, examples, uses/applications

UNIT-I 10 Hours

Stereo isomerism
Optical isomerism –
Optical activity, enantiomerism, diastereoisomerism, meso compounds
Elements of symmetry, chiral and achiral molecules
DL system of nomenclature of optical isomers, sequence rules, RS system of
nomenclature of optical isomers
Reactions of chiral molecules
Racemic modification and resolution of racemic mixture.
Asymmetric synthesis: partial and absolute

UNIT-II 10 Hours

Geometrical isomerism
Nomenclature of geometrical isomers (Cis Trans, EZ, Syn Anti systems)
Methods of determination of configuration of geometrical isomers.
Conformational isomerism in Ethane, n-Butane and Cyclohexane.
Stereo isomerism in biphenyl compounds (Atropisomerism) and conditions for optical
activity.
Stereospecific and stereoselective reactions

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

UNIT-III 10 Hours
Heterocyclic compounds:
Nomenclature and classification
Synthesis, reactions and medicinal uses of following compounds/derivatives
Pyrrole, Furan, and Thiophene

Relative aromaticity and reactivity of Pyrrole, Furan and Thiophene

UNIT-IV 8 Hours

Synthesis, reactions and medicinal uses of following compounds/derivatives


Pyrazole, Imidazole, Oxazole and Thiazole.
Pyridine, Quinoline, Isoquinoline, Acridine and Indole. Basicity of pyridine
Synthesis and medicinal uses of Pyrimidine, Purine, azepines and their derivatives

UNIT-V 07 Hours

Reactions of synthetic importance


Metal hydride reduction (NaBH4 and LiAlH4), Clemmensen reduction, Birch
reduction, Wolff Kishner reduction.
Oppenauer-oxidation and Dakin reaction.
Beckmanns rearrangement and Schmidt rearrangement.
Claisen-Schmidt condensation

Recommended Books (Latest Editions)


1. Organic chemistry by I.L. Finar, Volume-I & II.
2. A text book of organic chemistry – Arun Bahl, B.S. Bahl.
3. Heterocyclic Chemistry by Raj K. Bansal
4. Organic Chemistry by Morrison and Boyd
5. Heterocyclic Chemistry by T.L. Gilchrist

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP402T. MEDICINAL CHEMISTRY – I (Theory)


45 Hours
Scope: This subject is designed to impart fundamental knowledge on the structure,
chemistry and therapeutic value of drugs. The subject emphasizes on structure activity
relationships of drugs, importance of physicochemical properties and metabolism of drugs.
The syllabus also emphasizes on chemical synthesis of important drugs under each class.
Objectives: Upon completion of the course the student shall be able to
1. understand the chemistry of drugs with respect to their pharmacological activity
2. understand the drug metabolic pathways, adverse effect and therapeutic value of
drugs
3. know the Structural Activity Relationship (SAR) of different class of drugs
4. write the chemical synthesis of some drugs
Course Content:

Study of the development of the following classes of drugs, Classification, mechanism of


action, uses of drugs mentioned in the course, Structure activity relationship of selective class
of drugs as specified in the course and synthesis of drugs superscripted (*)

UNIT- I 10 Hours

Introduction to Medicinal Chemistry


History and development of medicinal chemistry
Physicochemical properties in relation to biological action
Ionization, Solubility, Partition Coefficient, Hydrogen bonding, Protein
binding, Chelation, Bioisosterism, Optical and Geometrical isomerism.
Drug metabolism
Drug metabolism principles- Phase I and Phase II.
Factors affecting drug metabolism including stereo chemical aspects.

UNIT- II 10 Hours

Drugs acting on Autonomic Nervous System

Adrenergic Neurotransmitters:
Biosynthesis and catabolism of catecholamine.
Adrenergic receptors (Alpha & Beta) and their distribution.

Sympathomimetic agents: SAR of Sympathomimetic agents


Direct acting: Nor-epinephrine, Epinephrine, Phenylephrine*, Dopamine,

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Methyldopa, Clonidine, Dobutamine, Isoproterenol, Terbutaline, Salbutamol*,


Bitolterol, Naphazoline, Oxymetazoline and Xylometazoline.
• Indirect acting agents: Hydroxyamphetamine, Pseudoephedrine,
Propylhexedrine.
• Agents with mixed mechanism: Ephedrine, Metaraminol.

Adrenergic Antagonists:
Alpha adrenergic blockers: Tolazoline*, Phentolamine, Phenoxybenzamine,
Prazosin, Dihydroergotamine, Methysergide.
Beta adrenergic blockers: SAR of beta blockers, Propranolol*,Metibranolol,
Atenolol, Betazolol, Bisoprolol, Esmolol, Metoprolol,Labetolol, Carvedilol.

UNIT-III 10 Hours

Cholinergic neurotransmitters:

Biosynthesis and catabolism of acetylcholine.


Cholinergic receptors (Muscarinic & Nicotinic) and their distribution.

Parasympathomimetic agents: SAR of Parasympathomimetic agents


Direct acting agents: Acetylcholine, Carbachol*, Bethanechol,
Methacholine, Pilocarpine.
Indirect acting/ Cholinesterase inhibitors (Reversible & Irreversible):
Physostigmine, Neostigmine*, Pyridostigmine, Edrophonium chloride,
Tacrine hydrochloride, Ambenonium chloride, Isofluorphate, Echothiophate
iodide, Parathione, Malathion.
Cholinesterase reactivator: Pralidoxime chloride.

Cholinergic Blocking agents: SAR of cholinolytic agents


Solanaceous alkaloids and analogues: Atropine sulphate, Hyoscyamine
sulphate, Scopolamine hydrobromide, Homatropine hydrobromide,
Ipratropium bromide*.
Synthetic cholinergic blocking agents: Tropicamide, Cyclopentolate
hydrochloride, Clidinium bromide, Dicyclomine hydrochloride*,
Glycopyrrolate, Methantheline bromide, Propantheline bromide, Benztropine
mesylate, Orphenadrine citrate, Biperidine hydrochloride, Procyclidine
hydrochloride*, Tridihexethyl chloride, Isopropamide iodide, Ethopropazine
hydrochloride.

UNIT- IV 08 Hours
Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Drugs acting on Central Nervous System

A. Sedatives and Hypnotics:


Benzodiazepines: SAR of Benzodiazepines, Chlordiazepoxide, Diazepam*,
Oxazepam, Chlorazepate, Lorazepam, Alprazolam, Zolpidem
Barbiturtes: SAR of barbiturates, Barbital*, Phenobarbital, Mephobarbital,
Amobarbital, Butabarbital, Pentobarbital, Secobarbital
Miscelleneous:
Amides & imides: Glutethmide.
Alcohol & their carbamate derivatives: Meprobomate, Ethchlorvynol.
Aldehyde & their derivatives: Triclofos sodium, Paraldehyde.

B. Antipsychotics
Phenothiazeines: SAR of Phenothiazeines - Promazine hydrochloride,
Chlorpromazine hydrochloride*, Triflupromazine, Thioridazine
hydrochloride, Piperacetazine hydrochloride, Prochlorperazine maleate,
Trifluoperazine hydrochloride.
Ring Analogues of Phenothiazeines: Chlorprothixene, Thiothixene,
Loxapine succinate, Clozapine.
Fluro buterophenones: Haloperidol, Droperidol, Risperidone.
Beta amino ketones: Molindone hydrochloride.
Benzamides: Sulpieride.

C. Anticonvulsants: SAR of Anticonvulsants, mechanism of anticonvulsant


action
Barbiturates: Phenobarbitone, Methabarbital. Hydantoins:
Phenytoin*, Mephenytoin, Ethotoin Oxazolidine diones:
Trimethadione, Paramethadione Succinimides:
Phensuximide, Methsuximide, Ethosuximide* Urea and
monoacylureas: Phenacemide, Carbamazepine*
Benzodiazepines: Clonazepam
Miscellaneous: Primidone, Valproic acid , Gabapentin, Felbamate

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

UNIT – V 07 Hours

Drugs acting on Central Nervous System


General anesthetics:
Inhalation anesthetics: Halothane*, Methoxyflurane, Enflurane,
Sevoflurane, Isoflurane, Desflurane.
Ultra short acting barbitutrates: Methohexital sodium*, Thiamylal sodium,
Thiopental sodium.
Dissociative anesthetics: Ketamine hydrochloride.*

Narcotic and non-narcotic analgesics


Morphine and related drugs: SAR of Morphine analogues, Morphine
sulphate, Codeine, Meperidine hydrochloride, Anilerdine hydrochloride,
Diphenoxylate hydrochloride, Loperamide hydrochloride, Fentanyl citrate*,
Methadone hydrochloride*, Propoxyphene hydrochloride, Pentazocine,
Levorphanol tartarate.
Narcotic antagonists: Nalorphine hydrochloride, Levallorphan tartarate,
Naloxone hydrochloride.
Anti-inflammatory agents: Sodium salicylate, Aspirin, Mefenamic acid*,
Meclofenamate, Indomethacin, Sulindac, Tolmetin, Zomepriac, Diclofenac,
Ketorolac, Ibuprofen*, Naproxen, Piroxicam, Phenacetin, Acetaminophen,
Antipyrine, Phenylbutazone.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP406P. MEDICINAL CHEMISTRY – I (Practical)


4 Hours/Week

I Preparation of drugs/ intermediates

1 1,3-pyrazole
2 1,3-oxazole
3 Benzimidazole
4 Benztriazole
5 2,3- diphenyl quinoxaline
6 Benzocaine
7 Phenytoin
8 Phenothiazine
9 Barbiturate

II Assay of drugs

1 Chlorpromazine
2 Phenobarbitone
3 Atropine
4 Ibuprofen
5 Aspirin
6 Furosemide

III Determination of Partition coefficient for any two drugs

Recommended Books (Latest Editions)


1. Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry.
2. Foye’s Principles of Medicinal Chemistry.
3. Burger’s Medicinal Chemistry, Vol I to IV.
4. Introduction to principles of drug design- Smith and Williams.
5. Remington’s Pharmaceutical Sciences.
6. Martindale’s extra pharmacopoeia.
7. Organic Chemistry by I.L. Finar, Vol. II.
8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.
9. Indian Pharmacopoeia.
10. Text book of practical organic chemistry- [Link].

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 403 T. PHYSICAL PHARMACEUTICS-II (Theory)


45Hours
Scope: The course deals with the various physica and physicochemical properties, and
principles involved in dosage forms/formulations. Theory and practical
components of the subject help the student to get a better insight into various areas
of formulation research and development, and stability studies of pharmaceutical
dosage forms.

Objectives: Upon the completion of the course student shall be able to


1. Understand various physicochemical properties of drug molecules in the
designing the dosage forms
2. Know the principles of chemical kinetics & to use them for stability testing nad
determination of expiry date of formulations
3. Demonstrate use of physicochemical properties in the formulation
development and evaluation of dosage forms.
Course Content:
UNIT-I 07 Hours

Colloidal dispersions: Classification of dispersed systems & their general characteristics,


size & shapes of colloidal particles, classification of colloids & comparative account of
their general properties. Optical, kinetic & electrical properties. Effect of electrolytes,
coacervation, peptization& protective action.

UNIT-II 10 Hours

Rheology: Newtonian systems, law of flow, kinematic viscosity, effect of temperature, non-
Newtonian systems, pseudoplastic, dilatant, plastic, thixotropy, thixotropy in formulation,
determination of viscosity, capillary, falling Sphere, rotational viscometers
Deformation of solids: Plastic and elastic deformation, Heckel equation, Stress, Strain,
Elastic Modulus

UNIT-III 10 Hours

Coarse dispersion: Suspension, interfacial properties of suspended particles, settling in


suspensions, formulation of flocculated and deflocculated suspensions. Emulsions and
theories of emulsification, microemulsion and multiple emulsions; Stability of emulsions,
preservation of emulsions, rheological properties of emulsions and emulsion formulation
by HLB method.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

UNIT-IV 10Hours

Micromeretics: Particle size and distribution, mean particle size, number and weight
distribution, particle number, methods for determining particle size by different methods,
counting and separation method, particle shape, specific surface, methods for determining
surface area, permeability, adsorption, derived properties of powders, porosity, packing
arrangement, densities, bulkiness & flow properties.

UNIT-V 10 Hours

Drug stability: Reaction kinetics: zero, pseudo-zero, first & second order, units of basic
rate constants, determination of reaction order. Physical and chemical factors influencing
the chemical degradation of pharmaceutical product: temperature, solvent, ionic strength,
dielectric constant, specific & general acid base catalysis, Simple numerical problems.
Stabilization of medicinal agents against common reactions like hydrolysis & oxidation.
Accelerated stability testing in expiration dating of pharmaceutical dosage forms.
Photolytic degradation and its prevention

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 407P. PHYSICAL PHARMACEUTICS- II (Practical)


3 Hrs/week

1. Determination of particle size, particle size distribution using sieving method


2. Determination of particle size, particle size distribution using Microscopic method
3. Determination of bulk density, true density and porosity
4. Determine the angle of repose and influence of lubricant on angle of repose

5. Determination of viscosity of liquid using Ostwald’s viscometer


6. Determination sedimentation volume with effect of different suspending agent
7. Determination sedimentation volume with effect of different concentration of
single suspending agent
8. Determination of viscosity of semisolid by using Brookfield viscometer
9. Determination of reaction rate constant first order.
10. Determination of reaction rate constant second order
11. Accelerated stability studies

Recommended Books: (Latest Editions)


1. Physical Pharmacy by Alfred Martin, Sixth edition
2. Experimental pharmaceutics by Eugene, Parott.
3. Tutorial pharmacy by Cooper and Gunn.
4. Stocklosam J. Pharmaceutical calculations, Lea & Febiger, Philadelphia.
5. Liberman H.A, Lachman C., Pharmaceutical Dosage forms, Tablets, Volume-1 to 3,
Marcel Dekkar Inc.
6. Liberman H.A, Lachman C, Pharmaceutical dosage forms. Disperse systems, volume 1,
2, 3. Marcel Dekkar Inc.
7. Physical Pharmaceutics by Ramasamy C, and Manavalan R.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 404 T. PHARMACOLOGY-I (Theory)


45 Hrs
Scope: The main purpose of the subject is to understand what drugs do to the living
organisms and how their effects can be applied to therapeutics. The subject covers the
information about the drugs like, mechanism of action, physiological and biochemical
effects (pharmacodynamics) as well as absorption, distribution, metabolism and excretion
(pharmacokinetics) along with the adverse effects, clinical uses, interactions, doses,
contraindications and routes of administration of different classes of drugs.
Objectives: Upon completion of this course the student should be able to
1. Understand the pharmacological actions of different categories of drugs
2. Explain the mechanism of drug action at organ system/sub cellular/
macromolecular levels.
3. Apply the basic pharmacological knowledge in the prevention and treatment of
various diseases.
4. Observe the effect of drugs on animals by simulated experiments
5. Appreciate correlation of pharmacology with other bio medical sciences
Course Content:
UNIT-I 08 hours
1. General Pharmacology
a. Introduction to Pharmacology- Definition, historical landmarks and scope of
pharmacology, nature and source of drugs, essential drugs concept and routes of
drug administration, Agonists, antagonists( competitive and non competitive), spare
receptors, addiction, tolerance, dependence, tachyphylaxis, idiosyncrasy, allergy.
b. Pharmacokinetics- Membrane transport, absorption, distribution, metabolism and
excretion of drugs .Enzyme induction, enzyme inhibition, kinetics of elimination
UNIT-II 12 Hours

General Pharmacology
a. Pharmacodynamics- Principles and mechanisms of drug action. Receptor theories
and classification of receptors, regulation of receptors. drug receptors interactions
signal transduction mechanisms, G-protein–coupled receptors, ion channel receptor,
transmembrane enzyme linked receptors, transmembrane JAK-STAT binding
receptor and receptors that regulate transcription factors, dose response
relationship, therapeutic index, combined effects of drugs and factors modifying
drug action.
b. Adverse drug reactions.
c. Drug interactions (pharmacokinetic and pharmacodynamic)
d. Drug discovery and clinical evaluation of new drugs -Drug discovery phase,
preclinical evaluation phase, clinical trial phase, phases of clinical trials and
pharmacovigilance.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

UNIT-III 10 Hours
2. Pharmacology of drugs acting on peripheral nervous system
a. Organization and function of ANS.
[Link] transmission,co-transmission and classification of neurotransmitters.
c. Parasympathomimetics, Parasympatholytics, Sympathomimetics, sympatholytics.
d. Neuromuscular blocking agents and skeletal muscle relaxants (peripheral).
e. Local anesthetic agents.
f. Drugs used in myasthenia gravis and glaucoma

UNIT-IV 08 Hours
3. Pharmacology of drugs acting on central nervous system
a. Neurohumoral transmission in the [Link] emphasis on importance of various
neurotransmitters like with GABA, Glutamate, Glycine, serotonin, dopamine.
b. General anesthetics and pre-anesthetics.
c. Sedatives, hypnotics and centrally acting muscle relaxants.
d. Anti-epileptics
e. Alcohols and disulfiram

UNIT-V 07 Hours
3. Pharmacology of drugs acting on central nervous system
a. Psychopharmacological agents: Antipsychotics, antidepressants, anti-anxiety agents,
anti-manics and hallucinogens.
b. Drugs used in Parkinsons disease and Alzheimer’s disease.
c. CNS stimulants and nootropics.
d. Opioid analgesics and antagonists
e. Drug addiction, drug abuse, tolerance and dependence.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 408 [Link]-I (Practical)


4Hrs/Week

1. Introduction to experimental pharmacology.


2. Commonly used instruments in experimental pharmacology.
3. Study of common laboratory animals.
4. Maintenance of laboratory animals as per CPCSEA guidelines.
5. Common laboratory techniques. Blood withdrawal, serum and plasma separation,
anesthetics and euthanasia used for animal studies.
6. Study of different routes of drugs administration in mice/rats.
7. Study of effect of hepatic microsomal enzyme inducers on the phenobarbitone sleeping
time in mice.
8. Effect of drugs on ciliary motility of frog oesophagus
9. Effect of drugs on rabbit eye.
10. Effects of skeletal muscle relaxants using rota-rod apparatus.
11. Effect of drugs on locomotor activity using actophotometer.
12. Anticonvulsant effect of drugs by MES and PTZ method.
13. Study of stereotype and anti-catatonic activity of drugs on rats/mice.
14. Study of anxiolytic activity of drugs using rats/mice.
15. Study of local anesthetics by different methods
Note: All laboratory techniques and animal experiments are demonstrated by simulated
experiments by softwares and videos

Recommended Books (Latest Editions)


1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale’s
Pharmacology,.Churchil Livingstone Elsevier
2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology,
Tata McGraw-Hill
3. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics
4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A.
K., Bradley R.W., Applied Therapeutics, The Clinical use of Drugs, The Point Lippincott
Williams & Wilkins
5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott’s Illustrated Reviews-
Pharmacology

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

6. [Link]. Essentials of Medical Pharmacology, JAYPEE Brothers Medical


Publishers (P) Ltd, New Delhi.
7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher
8. Modern Pharmacology with clinical Applications, by Charles [Link]& Robert,
9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company,
Kolkata.
10. Kulkarni SK. Handbook of experimental pharmacology. VallabhPrakashan,

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 405 [Link] AND PHYTOCHEMISTRY I (Theory)


45 Hours
Scope: The subject involves the fundamentals of Pharmacognosy like scope, classification of
crude drugs, their identification and evaluation, phytochemicals present in them and their
medicinal properties.

Objectives: Upon completion of the course, the student shall be able


1. to know the techniques in the cultivation and production of crude drugs
2. to know the crude drugs, their uses and chemical nature
3. know the evaluation techniques for the herbal drugs
4. to carry out the microscopic and morphological evaluation of crude drugs

Course Content:

UNIT-I 10 Hours
Introduction to Pharmacognosy:
(a) Definition, history, scope and development of Pharmacognosy
(b) Sources of Drugs – Plants, Animals, Marine & Tissue culture
(c) Organized drugs, unorganized drugs (dried latex, dried juices, dried extracts, gums and
mucilages, oleoresins and oleo- gum -resins).

Classification of drugs:
Alphabetical, morphological, taxonomical, chemical, pharmacological, chemo and sero
taxonomical classification of drugs

Quality control of Drugs of Natural Origin:


Adulteration of drugs of natural origin. Evaluation by organoleptic, microscopic, physical,
chemical and biological methods and properties.

Quantitative microscopy of crude drugs including lycopodium spore method, leafconstants,


camera lucida and diagrams of microscopic objects to scale with camera lucida.

UNIT-II 10 Hours
Cultivation, Collection, Processing and storage of drugs of natural origin:
Cultivation and Collection of drugs of natural origin
Factors influencing cultivation of medicinal plants.
Plant hormones and their applications.
Polyploidy, mutation and hybridization with reference to medicinal plants

Conservation of medicinal plants

UNIT-III 07 Hours
Plant tissue culture:
Historical development of plant tissue culture, types of cultures, Nutritional requirements,
growth and their maintenance.
Applications of plant tissue culture in pharmacognosy.
Edible vaccines

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

UNIT IV 10 Hours
Pharmacognosy in various systems of medicine:
Role of Pharmacognosy in allopathy and traditional systems of medicine namely, Ayurveda,
Unani, Siddha, Homeopathy and Chinese systems of medicine.

Introduction to secondary metabolites:


Definition, classification, properties and test for identification of Alkaloids, Glycosides,
Flavonoids, Tannins, Volatile oil and Resins

UNIT V 08 Hours
Study of biological source, chemical nature and uses of drugs of natural origin containing
following drugs
Plant Products:
Fibers - Cotton, Jute, Hemp
Hallucinogens, Teratogens, Natural allergens

Primary metabolites:
General introduction, detailed study with respect to chemistry, sources, preparation,
evaluation, preservation, storage, therapeutic used and commercial utility as Pharmaceutical
Aids and/or Medicines for the following Primary metabolites:
Carbohydrates: Acacia, Agar, Tragacanth, Honey
Proteins and Enzymes : Gelatin, casein, proteolytic enzymes (Papain, bromelain,
serratiopeptidase, urokinase, streptokinase, pepsin).
Lipids(Waxes, fats, fixed oils) : Castor oil, Chaulmoogra oil, Wool Fat, Bees Wax
Marine Drugs:
Novel medicinal agents from marine sources

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP408 P. PHARMACOGNOSY AND PHYTOCHEMISTRY I (Practical)


4 Hours/Week
1. Analysis of crude drugs by chemical tests: (i)Tragaccanth (ii) Acacia (iii)Agar (iv)
Gelatin (v) starch (vi) Honey (vii) Castor oil
2. Determination of stomatal number and index
3. Determination of vein islet number, vein islet termination and paliside ratio.
4. Determination of size of starch grains, calcium oxalate crystals by eye piece
micrometer
5. Determination of Fiber length and width
6. Determination of number of starch grains by Lycopodium spore method
7. Determination of Ash value
8. Determination of Extractive values of crude drugs
9. Determination of moisture content of crude drugs
10. Determination of swelling index and foaming

Recommended Books: (Latest Editions)


1. [Link], Trease and Evans Pharmacognosy, 16th edition, W.B. Sounders & Co.,
London, 2009.
2. Tyler, V.E., Brady, L.R. and Robbers, J.E., Pharmacognosy, 9th Edn., Lea and
Febiger, Philadelphia, 1988.
3. Text Book of Pharmacognosy by T.E. Wallis
4. Mohammad Ali. Pharmacognosy and Phytochemistry, CBS Publishers &
Distribution, New Delhi.
5. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae (2007), 37th Edition,
Nirali Prakashan, New Delhi.
6. Herbal drug industry by R.D. Choudhary (1996), Ist Edn, Eastern Publisher, New
Delhi.
7. Essentials of Pharmacognosy, [Link], IInd edition, Birla publications, New
Delhi, 2007
8. Practical Pharmacognosy: C.K. Kokate, Purohit, Gokhlae
9. Anatomy of Crude Drugs by M.A. Iyengar

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY


(Formerly Uttarakhand Technical University, Dehradun Established by Uttarakhand State Govt. wide Act no. 415 of 2005)
Suddhowala, PO-Chandanwadi, Premnagar, Dehradun, Uttarakhand (Website- [Link])

SYLLABUS
For

B. PHARMA
3rd Year (V SEMESTER)

Effective From – Session 2024-25

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

SEMESTER V

Evaluation pattern

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP501T. MEDICINAL CHEMISTRY – II (Theory)


45 Hours
Scope: This subject is designed to impart fundamental knowledge on the structure,
chemistry and therapeutic value of drugs. The subject emphasizes on structure activity
relationships of drugs, importance of physicochemical properties and metabolism of drugs.
The syllabus also emphasizes on chemical synthesis of important drugs under each class.
Objectives: Upon completion of the course the student shall be able to
1. Understand the chemistry of drugs with respect to their pharmacological activity
2. Understand the drug metabolic pathways, adverse effect and therapeutic value of
drugs
3. Know the Structural Activity Relationship of different class of drugs
4. Study the chemical synthesis of selected drugs
Course Content:

Study of the development of the following classes of drugs, Classification, mechanism


of action, uses of drugs mentioned in the course, Structure activity relationship of
selective class of drugs as specified in the course and synthesis of drugs superscripted
(*)

UNIT- I 10 Hours

Antihistaminic agents: Histamine, receptors and their distribution in the


humanbody
H1–antagonists: Diphenhydramine hydrochloride*, Dimenhydrinate,
Doxylamines cuccinate, Clemastine fumarate, Diphenylphyraline hydrochloride,
Tripelenamine hydrochloride, Chlorcyclizine hydrochloride, Meclizine
hydrochloride, Buclizine hydrochloride, Chlorpheniramine maleate, Triprolidine
hydrochloride*, Phenidamine tartarate, Promethazine hydrochloride*, Trimeprazine
tartrate, Cyproheptadine hydrochloride, Azatidine maleate, Astemizole, Loratadine,
Cetirizine, Levocetrazine Cromolyn sodium

H2-antagonists: Cimetidine*, Famotidine, Ranitidin.

Gastric Proton pump inhibitors: Omeprazole, Lansoprazole, Rabeprazole,


Pantoprazole

Anti-neoplastic agents:
Alkylating agents: Meclorethamine*, Cyclophosphamide, Melphalan,

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Chlorambucil, Busulfan, Thiotepa


Antimetabolites: Mercaptopurine*, Thioguanine, Fluorouracil, Floxuridine,
Cytarabine, Methotrexate*, Azathioprine
Antibiotics: Dactinomycin, Daunorubicin, Doxorubicin, Bleomycin
Plant products: Etoposide, Vinblastin sulphate, Vincristin sulphate
Miscellaneous: Cisplatin, Mitotane.

UNIT – II 10 Hours

Anti-anginal:
Vasodilators: Amyl nitrite, Nitroglycerin*, Pentaerythritol tetranitrate, Isosorbide
dinitrite*, Dipyridamole.
Calcium channel blockers: Verapamil, Bepridil hydrochloride, Diltiazem
hydrochloride, Nifedipine, Amlodipine, Felodipine, Nicardipine, Nimodipine.

Diuretics:
Carbonic anhydrase inhibitors: Acetazolamide*, Methazolamide,
Dichlorphenamide.
Thiazides: Chlorthiazide*, Hydrochlorothiazide, Hydroflumethiazide,
Cyclothiazide,
Loop diuretics: Furosemide*, Bumetanide, Ethacrynic acid.
Potassium sparing Diuretics: Spironolactone, Triamterene, Amiloride.
Osmotic Diuretics: Mannitol

Anti-hypertensive Agents: Timolol, Captopril, Lisinopril, Enalapril, Benazepril


hydrochloride, Quinapril hydrochloride, Methyldopate hydrochloride,* Clonidine
hydrochloride, Guanethidine monosulphate, Guanabenz acetate, Sodium
nitroprusside, Diazoxide, Minoxidil, Reserpine, Hydralazine hydrochloride.

UNIT- III 10 Hours

Anti-arrhythmic Drugs: Quinidine sulphate, Procainamide hydrochloride,


Disopyramide phosphate*, Phenytoin sodium, Lidocaine hydrochloride, Tocainide
hydrochloride, Mexiletine hydrochloride, Lorcainide hydrochloride, Amiodarone,
Sotalol.

Anti-hyperlipidemic agents: Clofibrate, Lovastatin, Cholesteramine and


Cholestipol

Coagulant & Anticoagulants: Menadione, Acetomenadione, Warfarin*,


Anisindione, clopidogrel

Drugs used in Congestive Heart Failure: Digoxin, Digitoxin, Nesiritide,


Bosentan, Tezosentan.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

UNIT- IV 08 Hours

Drugs acting on Endocrine system


Nomenclature, Stereochemistry and metabolism of steroids
Sex hormones: Testosterone, Nandralone, Progestrones, Oestriol, Oestradiol,
Oestrione, Diethyl stilbestrol.
Drugs for erectile dysfunction: Sildenafil, Tadalafil.
Oral contraceptives: Mifepristone, Norgestril, Levonorgestrol
Corticosteroids: Cortisone, Hydrocortisone, Prednisolone, Betamethasone,
Dexamethasone
Thyroid and antithyroid drugs: L-Thyroxine, L-Thyronine, Propylthiouracil,
Methimazole.

UNIT – V 07 Hours
Antidiabetic agents:
Insulin and its preparations
Sulfonyl ureas: Tolbutamide*, Chlorpropamide, Glipizide, Glimepiride.
Biguanides: Metformin.
Thiazolidinediones: Pioglitazone, Rosiglitazone.
Meglitinides: Repaglinide, Nateglinide.
Glucosidase inhibitors: Acrabose, Voglibose.

Local Anesthetics: SAR of Local anesthetics


Benzoic Acid derivatives; Cocaine, Hexylcaine, Meprylcaine, Cyclomethycaine,
Piperocaine.
Amino Benzoic acid derivatives: Benzocaine*, Butamben, Procaine*, Butacaine,
Propoxycaine, Tetracaine, Benoxinate.
Lidocaine/Anilide derivatives: Lignocaine, Mepivacaine, Prilocaine, Etidocaine.
Miscellaneous: Phenacaine, Diperodon, Dibucaine.*

Recommended Books (Latest Editions)


1. Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry.
2. Foye’s Principles of Medicinal Chemistry.
3. Burger’s Medicinal Chemistry, Vol I to IV.
4. Introduction to principles of drug design- Smith and Williams.
5. Remington’s Pharmaceutical Sciences.
6. Martindale’s extra pharmacopoeia.
7. Organic Chemistry by I.L. Finar, Vol. II.
8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1to 5.
9. Indian Pharmacopoeia.
10. Text book of practical organic chemistry- [Link].

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 502 T. Industrial PharmacyI (Theory)


45 Hours
Scope: Course enables the student to understand and appreciate the influence of
pharmaceutical additives and various pharmaceutical dosage forms on the performance of
the drug product.

Objectives: Upon completion of the course the student shall be able to


1. Know the various pharmaceutical dosage forms and their manufacturing
techniques.
2. Know various considerations in development of pharmaceutical dosage forms
3. Formulate solid, liquid and semisolid dosage forms and evaluate them for their
quality

Course content:
3 hours/ week
UNIT-I 07 Hours
Preformulation Studies: Introduction to preformulation, goals and objectives, study of
physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow
properties, solubility profile (pKa, pH, partition coefficient), polymorphism
b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization
BCS classification of drugs & its significant
Application of preformulation considerations in the development of solid, liquid oral and
parenteral dosage forms and its impact on stability of dosage forms.

UNIT-II 10 Hours
Tablets:
a. Introduction, ideal characteristics of tablets, classification of tablets. Excipients,
Formulation of tablets, granulation methods, compression and processing problems.
Equipments and tablet tooling.
b. Tablet coating: Types of coating, coating materials, formulation of coating
composition, methods of coating, equipment employed and defects in coating.
c. Quality control tests: In process and finished product tests

Liquid orals: Formulation and manufacturing consideration of syrups and elixirs


suspensions and emulsions; Filling and packaging; evaluation of liquid orals official
in pharmacopoeia

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

UNIT-III 08 Hours
Capsules:
a. Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. size
of capsules, Filling, finishing and special techniques of formulation of hard gelatin
capsules, manufacturing defects. In process and final product quality control tests for
capsules.
b. Soft gelatin capsules: Nature of shell and capsule content, size of capsules,importance
of base adsorption and minim/gram factors, production, in process and final product
quality control tests. Packing, storage and stability testing of soft gelatin capsules and
their applications.
Pellets: Introduction, formulation requirements, pelletization process, equipments for
manufacture of pellets

UNIT-IV 10 Hours
Parenteral Products:
a. Definition, types, advantages and limitations. Preformulation factors and essential
requirements, vehicles, additives, importance of isotonicity
b. Production procedure, production facilities and controls,
aseptic processing
c. Formulation of injections, sterile powders, large volume parenterals and
lyophilized products.
d. Containers and closures selection, filling and sealing of ampoules, vials and infusion
fluids. Quality control tests of parenteral products.
Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye
drops, eye ointments and eye lotions; methods of preparation; labeling, containers;
evaluation of ophthalmic preparations
UNIT-V 10 Hours
Cosmetics: Formulation and preparation of the following cosmetic preparations: lipsticks,
shampoos, cold cream and vanishing cream, tooth pastes, hair dyes and sunscreens.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol
systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control
and stability studies.
Packaging Materials Science: Materials used for packaging of pharmaceutical products,
factors influencing choice of containers, legal and official requirements for containers,
stability aspects of packaging materials, quality control tests.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 506 P. Industrial PharmacyI (Practical)


4 Hours/week
1. Preformulation studies on paracetamol/asparin/or any other drug
2. Preparation and evaluation of Paracetamol tablets
3. Preparation and evaluation of Aspirin tablets
4. Coating of tablets- film coating of tables/granules
5. Preparation and evaluation of Tetracycline capsules
6. Preparation of Calcium Gluconate injection
7. Preparation of Ascorbic Acid injection
8. Qulaity control test of (as per IP) marketed tablets and capsules
9. Preparation of Eye drops/ and Eye ointments
10. Preparation of Creams (cold / vanishing cream)
11. Evaluation of Glass containers (as per IP)

Recommended Books: (Latest Editions)


1. Pharmaceutical dosage forms - Tablets, volume 1 -3 by H.A. Liberman, Leon Lachman
&[Link]
2. Pharmaceutical dosage form - Parenteral medication vol- 1&2 by Liberman &
Lachman
3. Pharmaceutical dosage form disperse system VOL-1 by Liberman & Lachman
4. Modern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes, 3rd Edition
5. Remington: The Science and Practice of Pharmacy, 20th edition Pharmaceutical
Science (RPS)
6. Theory and Practice of Industrial Pharmacy by Liberman & Lachman
7. Pharmaceutics- The science of dosage form design by [Link], Churchill
livingstone, Latest edition
8. Introduction to Pharmaceutical Dosage Forms by H. [Link], Lea &Febiger,
Philadelphia, 5thedition, 2005
9. Drug stability - Principles and practice by Cartensen & C.J. Rhodes, 3rd Edition,
Marcel Dekker Series, Vol 107.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP503.T. PHARMACOLOGY-II (Theory)


45 Hours

Scope: This subject is intended to impart the fundamental knowledge on various aspects
(classification, mechanism of action, therapeutic effects, clinical uses, side effects and
contraindications) of drugs acting on different systems of body and in addition,emphasis on
the basic concepts of bioassay.

Objectives: Upon completion of this course the student should be able to


1. Understand the mechanism of drug action and its relevance in the treatment of
different diseases
2. Demonstrate isolation of different organs/tissues from the laboratory animals by
simulated experiments
3. Demonstrate the various receptor actions using isolated tissue preparation
4. Appreciate correlation of pharmacology with related medical sciences
Course Content:
UNIT-I 10hours
1. Pharmacology of drugs acting on cardio vascular system
a. Introduction to hemodynamic and electrophysiology of heart.
b. Drugs used in congestive heart failure
c. Anti-hypertensive drugs.
d. Anti-anginal drugs.
e. Anti-arrhythmic drugs.
f. Anti-hyperlipidemic drugs.

UNIT-II 10hours
1. Pharmacology of drugs acting on cardio vascular system
a. Drug used in the therapy of shock.
b. Hematinics, coagulants and anticoagulants.
c. Fibrinolytics and anti-platelet drugs
d. Plasma volume expanders
2. Pharmacology of drugs acting on urinary system
a. Diuretics
b. Anti-diuretics.

UNIT-III 10hours
3. Autocoids and related drugs
a. Introduction to autacoids and classification
b. Histamine, 5-HT and their antagonists.
c. Prostaglandins, Thromboxanes and Leukotrienes.
d. Angiotensin, Bradykinin and Substance P.
e. Non-steroidal anti-inflammatory agents
f. Anti-gout drugs
g. Antirheumatic drugs

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

UNIT-IV 08hours
5. Pharmacology of drugs acting on endocrine system
a. Basic concepts in endocrine pharmacology.
b. Anterior Pituitary hormones- analogues and their inhibitors.
c. Thyroid hormones- analogues and their inhibitors.
d. Hormones regulating plasma calcium level- Parathormone, Calcitonin and
Vitamin-D.
d. Insulin, Oral Hypoglycemic agents and glucagon.
e. ACTH and corticosteroids.

UNIT-V 07hours
5. Pharmacology of drugs acting on endocrine system
a. Androgens and Anabolic steroids.
b. Estrogens, progesterone and oral contraceptives.
c. Drugs acting on the uterus.
6. Bioassay
a. Principles and applications of bioassay.
[Link] of bioassay
c. Bioassay of insulin, oxytocin, vasopressin, ACTH,d-tubocurarine,digitalis, histamine
and 5-HT

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 507 P. PHARMACOLOGY-II (Practical)


4Hrs/Week

1. Introduction to in-vitro pharmacology and physiological salt solutions.


2. Effect of drugs on isolated frog heart.
3. Effect of drugs on blood pressure and heart rate of dog.
4. Study of diuretic activity of drugs using rats/mice.
5. DRC of acetylcholine using frog rectus abdominis muscle.
6. Effect of physostigmine and atropine on DRC of acetylcholine using frog rectus
abdominis muscle and rat ileum respectively.
7. Bioassay of histamine using guinea pig ileum by matching method.
8. Bioassay of oxytocin using rat uterine horn by interpolation method.
9. Bioassay of serotonin using rat fundus strip by three point bioassay.
10. Bioassay of acetylcholine using rat ileum/colon by four point bioassay.
11. Determination of PA2 value of prazosin using rat anococcygeus muscle (by
Schilds plot method).
12. Determination of PD2 value using guinea pig ileum.
13. Effect of spasmogens and spasmolytics using rabbit jejunum.
14. Anti-inflammatory activity of drugs using carrageenan induced paw-edema
model.
15. Analgesic activity of drug using central and peripheral methods

Note: All laboratory techniques and animal experiments are demonstrated by simulated
experiments by softwares and videos

Recommended Books (Latest Editions)


1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale’s Pharmacology,
Churchil Livingstone Elsevier
2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc
Graw-Hill.
3. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics
4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A.
K., Bradley R.W., Applied Therapeutics, The Clinical use of Drugs, The Point
Lippincott Williams & Wilkins.
5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott’s Illustrated Reviews-
Pharmacology.
6. [Link]. Essentials of Medical Pharmacology, , JAYPEE Brothers Medical
Publishers (P) Ltd, New Delhi.
7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher
8. Modern Pharmacology with clinical Applications, by Charles [Link]& Robert.
9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company,
Kolkata.
10. Kulkarni SK. Handbook of experimental pharmacology. Vallabh Prakashan.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP504 T. PHARMACOGNOSY AND PHYTOCHEMISTRY II (Theory)


45Hours
Scope: The main purpose of subject is to impart the students the knowledge of how the
secondary metabolites are produced in the crude drugs, how to isolate and identify and
produce them industrially. Also this subject involves the study of producing the plants and
phytochemicals through plant tissue culture, drug interactions and basic principles of
traditional system of medicine
Objectives: Upon completion of the course, the student shall be able
1. to know the modern extraction techniques, characterization and identification of the
herbal drugs and phytoconstituents
2. to understand the preparation and development of herbal formulation.
3. to understand the herbal drug interactions
4. to carryout isolation and identification of phytoconstituents

Course Content:
UNIT-I 7 Hours
Metabolic pathways in higher plants and their determination
a) Brief study of basic metabolic pathways and formation of different secondary metabolites
through these pathways- Shikimic acid pathway, Acetate pathways and Amino acid pathway.
b) Study of utilization of radioactive isotopes in the investigation of Biogenetic studies.

UNIT-II 14 Hours
General introduction, composition, chemistry & chemical classes, biosources, therapeutic
uses and commercial applications of following
secondary metabolites:

Alkaloids: Vinca, Rauwolfia, Belladonna, Opium,


Phenylpropanoids and Flavonoids: Lignans, Tea, Ruta
Steroids, Cardiac Glycosides & Triterpenoids: Liquorice, Dioscorea, Digitalis
Volatile oils: Mentha, Clove, Cinnamon, Fennel, Coriander,
Tannins: Catechu, Pterocarpus
Resins: Benzoin, Guggul, Ginger, Asafoetida, Myrrh, Colophony
Glycosides: Senna, Aloes, Bitter Almond
Iridoids, Other terpenoids & Naphthaquinones: Gentian, Artemisia, taxus, carotenoids
UNIT-III 06 Hours
Isolation, Identification and Analysis of Phytoconstituents
a) Terpenoids: Menthol, Citral, Artemisin
b) Glycosides: Glycyrhetinic acid & Rutin
c) Alkaloids: Atropine,Quinine,Reserpine,Caffeine
d) Resins: Podophyllotoxin, Curcumin
UNIT-IV 10 Hours
Industrial production, estimation and utilization of the following phytoconstituents:
Forskolin, Sennoside, Artemisinin, Diosgenin, Digoxin, Atropine, Podophyllotoxin, Caffeine,
Taxol, Vincristine and Vinblastine

UNIT V 8 Hours
Basics of Phytochemistry
Modern methods of extraction, application of latest techniques like Spectroscopy,
chromatography and electrophoresis in the isolation, purification and identification of crude
drugs.
Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 508 P. PHARMACOGNOSY AND PHYTOCHEMISTRY II (Practical)


4 Hours/Week

1. Morphology, histology and powder characteristics & extraction & detection of:
Cinchona, Cinnamon, Senna, Clove, Ephedra, Fennel and Coriander
2. Exercise involving isolation & detection of active principles
a. Caffeine - from tea dust.
b. Diosgenin from Dioscorea
c. Atropine from Belladonna
d. Sennosides from Senna
3. Separation of sugars by Paper chromatography
4. TLC of herbal extract
5. Distillation of volatile oils and detection of phytoconstitutents by TLC
6. Analysis of crude drugs by chemical tests: (i) Asafoetida (ii) Benzoin (iii)
Colophony (iv) Aloes (v) Myrrh

Recommended Books: (Latest Editions)


1. [Link], Trease and Evans Pharmacognosy, 16th edition, W.B. Sounders & Co.,
London, 2009.
2. Mohammad Ali. Pharmacognosy and Phytochemistry, CBS Publishers &
Distribution, New Delhi.
3. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae (2007), 37th Edition,
Nirali Prakashan, New Delhi.
4. Herbal drug industry by R.D. Choudhary (1996), Ist Edn, Eastern Publisher, New
Delhi.
5. Essentials of Pharmacognosy, [Link], IInd edition, Birla publications, New
Delhi, 2007
6. Herbal Cosmetics by [Link], Asia Pacific Business press, Inc, New Delhi.
7. A.N. Kalia, Textbook of Industrial Pharmacognosy, CBS Publishers, New Delhi,
2005.
8. R Endress, Plant cell Biotechnology, Springer-Verlag, Berlin, 1994.
9. Pharmacognosy & Pharmacobiotechnology. James Bobbers, Marilyn KS, VE Tylor.
10. The formulation and preparation of cosmetic, fragrances and flavours.
11. Remington’s Pharmaceutical sciences.
12. Text Book of Biotechnology by Vyas and Dixit.
13. Text Book of Biotechnology by R.C. Dubey.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 505 T. PHARMACEUTICAL JURISPRUDENCE (Theory)


45 Hours

Scope: This course is designed to impart basic knowledge on important


legislations related to the profession of pharmacy in India.

Objectives: Upon completion of the course, the student shall be able to understand:
1. The Pharmaceutical legislations and their implications in the development and
marketing of pharmaceuticals.
2. Various Indian pharmaceutical Acts and Laws
3. The regulatory authorities and agencies governing the manufacture and sale of
pharmaceuticals
4. The code of ethics during the pharmaceutical practice
Course Content:

UNIT-I 10 Hours

Drugs and Cosmetics Act, 1940 and its rules 1945:


Objectives, Definitions, Legal definitions of schedules to the Act and
Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.

UNIT-II 10 Hours

Drugs and Cosmetics Act, 1940 and its rules 1945.


Detailed study of Schedule G, H, M, N, P,T,U, V, X, Y, Part XII B, Sch F & DMR (OA)
Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and penalties
Labeling & Packing of drugs- General labeling requirements and specimen labels for drugs
and cosmetics, List of permitted colors. Offences and penalties.
Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugs
Laboratory, Drugs Consultative Committee, Government drug analysts, Licensing
authorities, controlling authorities, Drugs Inspectors

UNIT-III 10 Hours

• Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; its


constitution and functions, Education Regulations, State and Joint state pharmacy
councils; constitution and functions, Registration of Pharmacists, Offences and

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Penalties
• Medicinal and Toilet Preparation Act –1955: Objectives, Definitions, Licensing,
Manufacture In bond and Outside bond, Export of alcoholic preparations, Manufacture
of Ayurvedic, Homeopathic, Patent & Proprietary Preparations. Offences and
Penalties.
• Narcotic Drugs and Psychotropic substances Act-1985 and Rules: Objectives,
Definitions, Authorities and Officers, Constitution and Functions of narcotic &
Psychotropic Consultative Committee, National Fund for Controlling the Drug Abuse,
Prohibition, Control and Regulation, opium poppy cultivation and production of poppy
straw, manufacture, sale and export of opium, Offences and Penalties

UNIT-IV 08 Hours

• Study of Salient Features of Drugs and Magic Remedies Act and its rules:
Objectives, Definitions, Prohibition of certain advertisements, Classes of Exempted
advertisements, Offences and Penalties
• Prevention of Cruelty to animals Act-1960: Objectives, Definitions, Institutional
Animal Ethics Committee, CPCSEA guidelines for Breeding and Stocking of Animals,
Performance of Experiments, Transfer and acquisition of animals for experiment,
Records, Power to suspend or revoke registration, Offences and Penalties
• National Pharmaceutical Pricing Authority: Drugs Price Control Order (DPCO)-
2013. Objectives, Definitions, Sale prices of bulk drugs, Retail price of formulations,
Retail price and ceiling price of scheduled formulations, National List of Essential
Medicines (NLEM)

UNIT-V 07 Hours

• Pharmaceutical Legislations – A brief review, Introduction, Study of drugs enquiry


committee, Health survey and development committee, Hathi committee and Mudaliar
committee
• Code of Pharmaceutical ethics D efinition, Pharmacist in relation to his job, trade,
medical profession and his profession, Pharmacist’s oath
• Medical Termination of Pregnancy Act
• Right to Information Act
• Introduction to Intellectual Property Rights (IPR)

Recommended books: (Latest Edition)


1. Forensic Pharmacy by B. Suresh

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

2. Text book of Forensic Pharmacy by B.M. Mithal


3. Hand book of drug law-by M.L. Mehra
4. A text book of Forensic Pharmacy by N.K. Jain
5. Drugs and Cosmetics Act/Rules by Govt. of India publications.
6. Medicinal and Toilet preparations act 1955 by Govt. of India publications.
7. Narcotic drugs and psychotropic substances act by Govt. of India publications
8. Drugs and Magic Remedies act by Govt. of India publication
[Link] Acts of the said laws published by Government. Reference books (Theory)

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY


(Formerly Uttarakhand Technical University, Dehradun Established by Uttarakhand State Govt. wide Act no. 415 of 2005)
Suddhowala, PO-Chandanwadi, Premnagar, Dehradun, Uttarakhand (Website- [Link])

SYLLABUS
For

B. PHARMA
3rd Year (VI SEMESTER)

Effective From – Session 2024-25

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

SEMESTER VI

Evaluation pattern

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VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP601T. MEDICINAL CHEMISTRY – III (Theory)


45 Hours
Scope: This subject is designed to impart fundamental knowledge on the structure,
chemistry and therapeutic value of drugs. The subject emphasis on modern techniques of
rational drug design like quantitative structure activity relationship (QSAR), Prodrug
concept, combinatorial chemistry and Computer aided drug design (CADD). The subject
also emphasizes on the chemistry, mechanism of action, metabolism, adverse effects,
Structure Activity Relationships (SAR), therapeutic uses and synthesis of important drugs.

Objectives: Upon completion of the course student shall be able to


1. Understand the importance of drug design and different techniques of drug
design.
2. Understand the chemistry of drugs with respect to their biological activity.
3. Know the metabolism, adverse effects and therapeutic value of drugs.
4. Know the importance of SAR of drugs.
Course Content:

Study of the development of the following classes of drugs, Classification, mechanism of


action, uses of drugs mentioned in the course, Structure activity relationship of selective class
of drugs as specified in the course and synthesis of drugs superscripted by (*)

UNIT – I 10 Hours

Antibiotics
Historical background, Nomenclature, Stereochemistry, Structure activity
relationship, Chemical degradation classification and important products of the
following classes.
β-Lactam antibiotics: Penicillin, Cepholosporins, β- Lactamase inhibitors,
Monobactams
Aminoglycosides: Streptomycin, Neomycin, Kanamycin
Tetracyclines: Tetracycline,Oxytetracycline, Chlortetracycline,
Minocycline, Doxycycline

UNIT – II 10 Hours

Antibiotics
Historical background, Nomenclature, Stereochemistry, Structure activity
relationship, Chemical degradation classification and important products of the
following classes.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Macrolide: Erythromycin Clarithromycin, Azithromycin.


Miscellaneous: Chloramphenicol*, Clindamycin.

Prodrugs: Basic concepts and application of prodrugs design.

Antimalarials: Etiology of malaria.


Quinolines: SAR, Quinine sulphate, Chloroquine*, Amodiaquine,
Primaquine phosphate, Pamaquine*, Quinacrine hydrochloride, Mefloquine.
Biguanides and dihydro triazines: Cycloguanil pamoate, Proguanil.
Miscellaneous: Pyrimethamine, Artesunete, Artemether, Atovoquone.

UNIT – III 10 Hours

Anti-tubercular Agents
Synthetic anti tubercular agents: Isoniozid*, Ethionamide, Ethambutol,
Pyrazinamide, Para amino salicylic acid.*
Anti tubercular antibiotics: Rifampicin, Rifabutin, Cycloserine
Streptomycine, Capreomycin sulphate.

Urinary tract anti-infective agents


Quinolones: SAR of quinolones, Nalidixic Acid,Norfloxacin, Enoxacin,
Ciprofloxacin*, Ofloxacin, Lomefloxacin, Sparfloxacin, Gatifloxacin,
Moxifloxacin
Miscellaneous: Furazolidine, Nitrofurantoin*, Methanamine.

Antiviral agents:
Amantadine hydrochloride, Rimantadine hydrochloride, Idoxuridine
trifluoride, Acyclovir*, Gancyclovir, Zidovudine, Didanosine, Zalcitabine,
Lamivudine, Loviride, Delavirding, Ribavirin, Saquinavir, Indinavir, Ritonavir.

UNIT – IV 08 Hours

Antifungal agents:
Antifungal antibiotics: Amphotericin-B, Nystatin, Natamycin, Griseofulvin.
Synthetic Antifungal agents: Clotrimazole, Econazole, Butoconazole,
Oxiconazole Tioconozole, Miconazole*, Ketoconazole, Terconazole,
Itraconazole, Fluconazole, Naftifine hydrochloride, Tolnaftate*.

Anti-protozoal Agents: Metronidazole*, Tinidazole, Ornidazole, Diloxanide,


Iodoquinol, Pentamidine Isethionate, Atovaquone, Eflornithine.

Anthelmintics: Diethylcarbamazine citrate*, Thiabendazole, Mebendazole*,


Albendazole, Niclosamide, Oxamniquine, Praziquantal, Ivermectin.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Sulphonamides and Sulfones


Historical development, chemistry, classification and SAR of Sulfonamides:
Sulphamethizole, Sulfisoxazole, Sulphamethizine, Sulfacetamide*,
Sulphapyridine, Sulfamethoxaole*, Sulphadiazine, Mefenide acetate,
Sulfasalazine.
Folate reductase inhibitors: Trimethoprim*, Cotrimoxazole.
Sulfones: Dapsone*.

UNIT – V 07 Hours

Introduction to Drug Design

Various approaches used in drug design.


Physicochemical parameters used in quantitative structure activity relationship
(QSAR) such as partition coefficient, Hammet’s electronic parameter, Tafts
steric parameter and Hansch analysis.
Pharmacophore modeling and docking techniques.

Combinatorial Chemistry: Concept and applications of combinatorial


chemistry: solid phase and solution phase synthesis.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP607P. MEDICINAL CHEMISTRY- III (Practical)


4 Hours / week

I Preparation of drugs and intermediates

1 Sulphanilamide
2 7-Hydroxy, 4-methyl coumarin
3 Chlorobutanol
4 Triphenyl imidazole
5 Tolbutamide
6 Hexamine

II Assay of drugs

1 Isonicotinic acid hydrazide


2 Chloroquine
3 Metronidazole
4 Dapsone
5 Chlorpheniramine maleate
6 Benzyl penicillin

III Preparation of medicinally important compounds or intermediates by Microwave


irradiation technique

IV Drawing structures and reactions using chem draw®

V Determination of physicochemical properties such as logP, clogP, MR, Molecular


weight, Hydrogen bond donors and acceptors for class of drugs course content using
drug design software Drug likeliness screening (Lipinskies RO5)

Recommended Books (Latest Editions)


1. Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry.
2. Foye’s Principles of Medicinal Chemistry.
3. Burger’s Medicinal Chemistry, Vol I to IV.
4. Introduction to principles of drug design- Smith and Williams.
5. Remington’s Pharmaceutical Sciences.
6. Martindale’s extra pharmacopoeia.
7. Organic Chemistry by I.L. Finar, Vol. II.
8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.
9. Indian Pharmacopoeia.
10. Text book of practical organic chemistry- [Link].

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP602 T. PHARMACOLOGY-III (Theory)

45 Hours

Scope: This subject is intended to impart the fundamental knowledge on various aspects
(classification, mechanism of action, therapeutic effects, clinical uses, side effects and
contraindications) of drugs acting on respiratory and gastrointestinal system, infectious
diseases, immuno-pharmacology and in addition,emphasis on the principles of toxicology
and chronopharmacology.

Objectives: Upon completion of this course the student should be able to:
1. understand the mechanism of drug action and its relevance in the treatment of
different infectious diseases
2. comprehend the principles of toxicology and treatment of various poisoningsand
3. appreciate correlation of pharmacology with related medical sciences.
Course Content:

UNIT-I 10hours
1. Pharmacology of drugs acting on Respiratory system
a. Anti -asthmatic drugs
b. Drugs used in the management of COPD
c. Expectorants and antitussives
d. Nasal decongestants
e. Respiratory stimulants

2. Pharmacology of drugs acting on the Gastrointestinal Tract


a. Antiulcer agents.
b. Drugs for constipation and diarrhoea.
c. Appetite stimulants and suppressants.
d. Digestants and carminatives.
e. Emetics and anti-emetics.

UNIT-II 10hours
3. Chemotherapy
a. General principles of chemotherapy.
b. Sulfonamides and cotrimoxazole.
c. Antibiotics- Penicillins, cephalosporins, chloramphenicol, macrolides,
quinolones and fluoroquinolins, tetracycline and aminoglycosides
UNIT-III 10hours
3. Chemotherapy
a. Antitubercular agents
b. Antileprotic agents

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

c. Antifungal agents
d. Antiviral drugs
[Link]
f. Antimalarial drugs
g. Antiamoebic agents
UNIT-IV 08hours
3. Chemotherapy
l. Urinary tract infections and sexually transmitted diseases.
m. Chemotherapy of malignancy.
4. Immunopharmacology
a. Immunostimulants
b. Immunosuppressant
Protein drugs, monoclonal antibodies, target drugs to antigen, biosimilars

UNIT-V 07hours
5. Principles of toxicology

a. Definition and basic knowledge of acute, subacute and chronic toxicity.


b. Definition and basic knowledge of genotoxicity, carcinogenicity, teratogenicity
and mutagenicity
c. General principles of treatment of poisoning
d. Clinical symptoms and management of barbiturates, morphine,
organophosphosphorus compound and lead, mercury and arsenic poisoning.

6. Chronopharmacology
a. Definition of rhythm and cycles.
b. Biological clock and their significance leading to chronotherapy.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 608 P. PHARMACOLOGY-III (Practical)


4Hrs/Week

1. Dose calculation in pharmacological experiments


2. Antiallergic activity by mast cell stabilization assay
3. Study of anti-ulcer activity of a drug using pylorus ligand (SHAY) rat model and
NSAIDS induced ulcer model.
4. Study of effect of drugs on gastrointestinal motility
5. Effect of agonist and antagonists on guinea pig ileum
6. Estimation of serum biochemical parameters by using semi- autoanalyser
7. Effect of saline purgative on frog intestine
8. Insulin hypoglycemic effect in rabbit
9. Test for pyrogens ( rabbit method)
10. Determination of acute oral toxicity (LD50) of a drug from a given data
11. Determination of acute skin irritation / corrosion of a test substance
12. Determination of acute eye irritation / corrosion of a test substance
13. Calculation of pharmacokinetic parameters from a given data
14. Biostatistics methods in experimental pharmacology( student’s t test, ANOVA)
15. Biostatistics methods in experimental pharmacology (Chi square test, Wilcoxon
Signed Rank test)

*Experiments are demonstrated by simulated experiments/videos

Recommended Books (Latest Editions)


1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale’s Pharmacology,
Churchil Livingstone Elsevier
2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc
Graw-Hill
3. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics
4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A.
K., Bradley R.W., Applied Therapeutics, The Clinical use of Drugs. The Point Lippincott
Williams & Wilkins
5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott’s Illustrated Reviews-
Pharmacology
6. [Link]. Essentials of Medical Pharmacology, , JAYPEE Brothers Medical
Publishers (P) Ltd, New Delhi.
7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher
Modern Pharmacology with clinical Applications, by Charles [Link]& Robert,
8. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company,
Kolkata,
9. Kulkarni SK. Handbook of experimental pharmacology. VallabhPrakashan,
10. [Link] and P.D. Gupta, Concepts in Chronopharmacology.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 603 T. HERBAL DRUG TECHNOLOGY (Theory)


45 hours
Scope: This subject gives the student the knowledge of basic understanding of herbal drug industry,
the quality of raw material, guidelines for quality of herbal drugs, herbal cosmetics, natural
sweeteners, nutraceutical etc. The subject also emphasizes on Good Manufacturing Practices (GMP),
patenting and regulatory issues of herbal drugs

Objectives: Upon completion of this course the student should be able to:
1. understand raw material as source of herbal drugs from cultivation to herbal drug
product
2. know the WHO and ICH guidelines for evaluation of herbal drugs
3. know the herbal cosmetics, natural sweeteners, nutraceuticals
4. appreciate patenting of herbal drugs, GMP .

Course content:
UNIT-I 11 Hours
Herbs as raw materials
Definition of herb, herbal medicine, herbal medicinal product, herbal drug preparation
Source of Herbs
Selection, identification and authentication of herbal materials
Processing of herbal raw material

Biodynamic Agriculture
Good agricultural practices in cultivation of medicinal plants including Organic farming.
Pest and Pest management in medicinal plants: Biopesticides/Bioinsecticides.

Indian Systems of Medicine


a) Basic principles involved in Ayurveda, Siddha, Unani and Homeopathy
b) Preparation and standardization of Ayurvedic formulations viz Aristas and Asawas,
Ghutika,Churna, Lehya and Bhasma.

UNIT-II 7 Hours
Nutraceuticals
General aspects, Market, growth, scope and types of products available in the market. Health
benefits and role of Nutraceuticals in ailments like Diabetes, CVS diseases, Cancer, Irritable
bowel syndrome and various Gastro intestinal diseases.
Study of following herbs as health food: Alfaalfa, Chicory, Ginger, Fenugreek, Garlic, Honey,
Amla, Ginseng, Ashwagandha, Spirulina

Herbal-Drug and Herb-Food Interactions: General introduction to interaction and


classification. Study of following drugs and their possible side effects and interactions:
Hypercium, kava-kava, Ginkobiloba, Ginseng, Garlic, Pepper & Ephedra.

UNIT-III 10 Hours
Herbal Cosmetics
Sources and description of raw materials of herbal origin used via, fixed oils, waxes, gums
colours, perfumes, protective agents, bleaching agents, antioxidants in products such as skin
care, hair care and oral hygiene products.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Herbal excipients:
Herbal Excipients – Significance of substances of natural origin as excipients – colorants,
sweeteners, binders, diluents, viscosity builders, disintegrants, flavors & perfumes.

Herbal formulations :
Conventional herbal formulations like syrups, mixtures and tablets and Novel dosage forms
like phytosomes

UNIT- IV 10 Hours
Evaluation of Drugs WHO & ICH guidelines for the assessment of herbal drugs
Stability testing of herbal drugs.

Patenting and Regulatory requirements of natural products:


a) Definition of the terms: Patent, IPR, Farmers right, Breeder’s right, Bioprospecting and
Biopiracy
b) Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma
& Neem.

Regulatory Issues - Regulations in India (ASU DTAB, ASU DCC), Regulation of


manufacture of ASU drugs - Schedule Z of Drugs & Cosmetics Act for ASU drugs.

UNIT-V 07 Hours
General Introduction to Herbal Industry
Herbal drugs industry: Present scope and future prospects.
A brief account of plant based industries and institutions involved in work on medicinal and
aromatic plants in India.

Schedule T – Good Manufacturing Practice of Indian systems of medicine


Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipments,
standard operating procedures, health and hygiene, documentation and records.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 609 P. HERBAL DRUG TECHNOLOGY (Practical)


4 hours/ week

1. To perform preliminary phytochemical screening of crude drugs.


2. Determination of the alcohol content of Asava and Arista
3. Evaluation of excipients of natural origin
4. Incorporation of prepared and standardized extract in cosmetic formulations like creams,
lotions and shampoos and their evaluation.
5. Incorporation of prepared and standardized extract in formulations like syrups, mixtures
and tablets and their evaluation as per Pharmacopoeial requirements.
6. Monograph analysis of herbal drugs from recent Pharmacopoeias
7. Determination of Aldehyde content
8. Determination of Phenol content
9. Determination of total alkaloids

Recommended Books: (Latest Editions)

1. Textbook of Pharmacognosy by Trease & Evans.


2. Textbook of Pharmacognosy by Tyler, Brady & Robber.
3. Pharmacognosy by Kokate, Purohit and Gokhale
4. Essential of Pharmacognosy by [Link]
5. Pharmacognosy & Phytochemistry by [Link]
6. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in
Indian Medicine & Homeopathy)
7. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of
Botanicals. Business Horizons Publishers, New Delhi, India, 2002.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 604 T. BIOPHARMACEUTICS AND PHARMACOKINETICS


(Theory)
45 Hours
Scope:This subject is designed to impart knowledge and skills of Biopharmaceutics and
pharmacokinetics and their applications in pharmaceutical development, design of dose
and dosage regimen and in solving the problems arised therein.
Objectives: Upon completion of the course student shall be able
to:
1. Understand the basic concepts in biopharmaceutics and pharmacokinetics and
their significance.
2. Use of plasma drug concentration-time data to calculate the pharmacokinetic
parameters to describe the kinetics of drug absorption, distribution,
metabolism, excretion, elimination.
3. To understand the concepts of bioavailability and bioequivalence of drug
products and their significance.
4. Understand various pharmacokinetic parameters, their significance &
applications.
Course
Content:
UNIT-I
10 Hours
Introduction to Biopharmaceutics
Absorption; Mechanisms of drug absorption through GIT, factors influencing drug
absorption though GIT, absorption of drug from Non per oral extra-vascular routes,
Distribution Tissue permeability of drugs, binding of drugs, apparent, volumeof drug
distribution, plasma and tissue protein binding of drugs, factors affecting protein-drug
binding. Kinetics of protein binding, Clinical significance of protein binding of drugs
UNIT- II 10 Hours
Elimination: Drug metabolism and basic understanding metabolic pathways renal
excretion of drugs, factors affecting renal excretion of drugs, renal clearance, Non renal
routes of drug excretion of drugs
Bioavailability and Bioequivalence: Definition and Objectives of bioavailability,
absolute and relative bioavailability, measurement of bioavailability, in-vitro drug
dissolution models, in-vitro-in-vivo correlations, bioequivalence studies, methods to
enhance the dissolution rates and bioavailability of poorly soluble drugs.

Syllabus of [Link]

UNIT- III 10 Hours


VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Pharmacokinetics: Definition and introduction to Pharmacokinetics, Compartment


models, Non compartment models, physiological models, One compartment open
model. (a). Intravenous Injection (Bolus) (b). Intravenous infusion and (c) Extra
vascular administrations. Pharmacokinetics parameters - KE ,t1/2,Vd,AUC,Ka, Clt and
CLR- definitions methods of eliminations, understanding of their significance and
application

UNIT- IV 08 Hours
Multicompartment models: Two compartment open model. IV bolus
Kinetics of multiple dosing, steady state drug levels, calculation of loading and
mainetnance doses and their significance in clinical settins.

UNIT- V 07 Hours
Nonlinear Pharmacokinetics: a. Introduction, b. Factors causing Non-linearity.
c. Michaelis-menton method of estimating parameters, Explanation with example of
drugs.

Recommended Books: (Latest Editions)


1. Biopharmaceutics and Clinical Pharmacokinetics by, Milo Gibaldi.
2. Biopharmaceutics and Pharmacokinetics; By Robert F Notari
3. Applied biopharmaceutics and pharmacokinetics, Leon Shargel and Andrew
[Link] 4th edition,Prentice-Hall Inernational [Link]
4. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and
Sunil [Link],Vallabh Prakashan Pitampura, Delhi
5. Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker Inc.
6. Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie Prescott by
ADIS Health Science Press.
7. Biopharmaceutics; By Swarbrick
8. Clinical Pharmacokinetics, Concepts and Applications: By Malcolm Rowland and
9. Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.
10. Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack,
Publishing Company,Pennsylvania 1989.
11. Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edition
Revised and expanded by Rebort F Notari Marcel Dekker Inn, New York and
Basel, 1987.
12. Remington’s Pharmaceutical Sciences, By Mack Publishing Company,
Pennsylvnia

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 605 T. PHARMACEUTICAL BIOTECHNOLOGY (Theory)

Scope: 45 Hours

• Biotechnology has a long promise to revolutionize the biological sciences and


technology.
• Scientific application of biotechnology in the field of genetic engineering,
medicine and fermentation technology makes the subject interesting.
• Biotechnology is leading to new biological revolutions in diagnosis, prevention
and cure of diseases, new and cheaper pharmaceutical drugs.
• Biotechnology has already produced transgenic crops and animals and the future
promises lot more.
• It is basically a research-based subject.
Objectives: Upon completion of the subject student shall be able to;
1. Understanding the importance of Immobilized enzymes in Pharmaceutical
Industries
2. Genetic engineering applications in relation to production of pharmaceuticals
3. Importance of Monoclonal antibodies in Industries
4. Appreciate the use of microorganisms in fermentation technology

Unit I 10 Hours

a) Brief introduction to Biotechnology with reference to Pharmaceutical Sciences.


b) Enzyme Biotechnology- Methods of enzyme immobilization and applications.
c) Biosensors- Working and applications of biosensors in Pharmaceutical Industries.
d) Brief introduction to Protein Engineering.
e) Use of microbes in industry. Production of Enzymes- General consideration -
Amylase, Catalase, Peroxidase, Lipase, Protease, Penicillinase.
f) Basic principles of genetic engineering.

Unit II 10 Hours

a) Study of cloning vectors, restriction endonucleases and DNA ligase.


b) Recombinant DNA technology. Application of genetic engineering in medicine.
c) Application of r DNA technology and genetic engineering in the production of:
i) Interferon ii) Vaccines- hepatitis- B iii) Hormones-Insulin.
d) Brief introduction to PCR

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Unit III 10 Hours

Types of immunity- humoral immunity, cellular immunity

a) Structure of Immunoglobulins
b) Structure and Function of MHC
c) Hypersensitivity reactions, Immune stimulation and Immune suppressions.
d) General method of the preparation of bacterial vaccines, toxoids, viral vaccine,
antitoxins, serum-immune blood derivatives and other products relative to immunity.
e) Storage conditions and stability of official vaccines
f) Hybridoma technology- Production, Purification and Applications

g) Blood products and Plasma Substituties.

Unit IV 08Hours

a) Immuno blotting techniques- ELISA, Western blotting, Southern blotting.


b) Genetic organization of Eukaryotes and Prokaryotes
c) Microbial genetics including transformation, transduction, conjugation, plasmids and
transposons.
d) Introduction to Microbial biotransformation and applications.
e) Mutation: Types of mutation/mutants.

Unit V 07 Hours

a) Fermentation methods and general requirements, study of media, equipments,


sterilization methods, aeration process, stirring.
b) Large scale production fermenter design and its various controls.
c) Study of the production of - penicillins, citric acid, Vitamin B12, Glutamic acid,
Griseofulvin,
d) Blood Products: Collection, Processing and Storage of whole human blood, dried
human plasma, plasma Substituties.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Recommended Books (Latest edition):


1. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and Applications
of RecombinantDNA: ASM Press Washington D.C.
2. RA Goldshy et. al., : Kuby Immunology.
3. J.W. Goding: Monoclonal Antibodies.
4. J.M. Walker and E.B. Gingold: Molecular Biology and Biotechnology by Royal
Society of Chemistry.
5. Zaborsky: Immobilized Enzymes, CRC Press, Degraland, Ohio.
6. S.B. Primrose: Molecular Biotechnology (Second Edition) Blackwell Scientific
Publication.
7. Stanbury F., P., Whitakar A., and Hall J., S., Principles of fermentation technology,
2nd edition, Aditya books Ltd., New Delhi

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP606T PHARMACEUTICAL QUALITY ASSURANCE (Theory)


45 Hours
Scope: This course deals with the various aspects of quality control and quality assurance
aspects of pharmaceutical industries. It deals with the important aspects like cGMP, QC
tests, documentation, quality certifications and regulatory affairs.
Objectives: Upon completion of the course student shall be able to:
• understand the cGMP aspects in a pharmaceutical industry
• appreciate the importance of documentation
• understand the scope of quality certifications applicable to pharmaceutical
industries
• understand the responsibilities of QA & QC departments
Course content:
UNIT – I 10 Hours
Quality Assurance and Quality Management concepts: Definition and concept of Quality
control, Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM,
with special emphasis on Q-series guidelines, ICH stability testing guidelines
Quality by design (QbD): Definition, overview, elements of QbD program, tools
ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
NABL accreditation : Principles and procedures

UNIT - II 10 Hours
Organization and personnel: Personnel responsibilities, training, hygiene and personal records.
Premises: Design, construction and plant layout, maintenance, sanitation, environmental control,
utilities and maintenance of sterile areas, control of contamination.
Equipments and raw materials: Equipment selection, purchase specifications, maintenance,
purchase specifications and maintenance of stores for raw materials.

UNIT – III 10 Hours


Quality Control: Quality control test for containers, rubber closures and secondary packing
materials.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities,
Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a
Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

UNIT – IV 08 Hours
Complaints: Complaints and evaluation of complaints, Handling of return good, recalling and
waste disposal.
Document maintenance in pharmaceutical industry: Batch Formula Record, Master Formula
Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and
documents, distribution records.

UNIT – V 07 Hours
Calibration and Validation: Introduction, definition and general principles of calibration,
qualification and validation, importance and scope of validation, types of validation, validation
master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General
principles of Analytical method Validation.
Warehousing: Good warehousing practice, materials management

Recommended Books: (Latest Edition)


1. Quality Assurance Guide by organization of Pharmaceutical Products of India.
2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69.
3. Quality Assurance of Pharmaceuticals- A compendium of Guide lines and Related
materials Vol I WHO Publications.
4. A guide to Total Quality Management- Kushik Maitra and Sedhan K Ghosh
5. How to Practice GMP’s – P P Sharma.
6. ISO 9000 and Total Quality Management – Sadhank G Ghosh
7. The International Pharmacopoeia – Vol I, II, III, IV- General Methods of Analysis
and Quality specification for Pharmaceutical Substances, Excipients and Dosage
forms
8. Good laboratory Practices – Marcel Deckker Series
9. ICH guidelines, ISO 9000 and 14000 guidelines

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY


(Formerly Uttarakhand Technical University, Dehradun Established by Uttarakhand State Govt. wide Act no. 415 of 2005)
Suddhowala, PO-Chandanwadi, Premnagar, Dehradun, Uttarakhand (Website- [Link])

SYLLABUS
For

B. PHARMA
4th Year (VII SEMESTER)

Effective From – Session 2025-26

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

SEMESTER VII

Evaluation pattern

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP701T. INSTRUMENTAL METHODS OF ANALYSIS (Theory)


45 Hours
Scope: This subject deals with the application of instrumental methods in qualitative and
quantitative analysis of drugs. This subject is designed to impart a fundamental knowledge
on the principles and instrumentation of spectroscopic and chromatographic technique. This
also emphasizes on theoretical and practical knowledge on modern analytical instruments
that are used for drug testing.

Objectives: Upon completion of the course the student shall be able to


1. Understand the interaction of matter with electromagnetic radiations and its
applications in drug analysis
2. Understand the chromatographic separation and analysis of drugs.
3. Perform quantitative & qualitative analysis of drugs using various analytical
instruments.

Course Content:

UNIT –I 10 Hours

UV Visible spectroscopy
Electronic transitions, chromophores, auxochromes, spectral shifts, solvent effect on
absorption spectra, Beer and Lambert’s law, Derivation and deviations.
Instrumentation - Sources of radiation, wavelength selectors, sample cells, detectors-
Photo tube, Photomultiplier tube, Photo voltaic cell, Silicon Photodiode.
Applications - Spectrophotometric titrations, Single component and multi component
analysis
Fluorimetry
Theory, Concepts of singlet, doublet and triplet electronic states, internal and external
conversions, factors affecting fluorescence, quenching, instrumentation and
applications

UNIT –II 10 Hours

IR spectroscopy
Introduction, fundamental modes of vibrations in poly atomic molecules, sample
handling, factors affecting vibrations
Instrumentation - Sources of radiation, wavelength selectors, detectors - Golay cell,
Bolometer, Thermocouple, Thermister, Pyroelectric detector and applications
Flame Photometry-Principle, interferences, instrumentation and applications

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Atomic absorption spectroscopy- Principle, interferences, instrumentation and


applications
Nepheloturbidometry- Principle, instrumentation and applications

UNIT –III 10 Hours

Introduction to chromatography
Adsorption and partition column chromatography-Methodology, advantages,
disadvantages and applications.
Thin layer chromatography- Introduction, Principle, Methodology, Rf values,
advantages, disadvantages and applications.
Paper chromatography-Introduction, methodology, development techniques,
advantages, disadvantages and applications
Electrophoresis– Introduction, factors affecting electrophoretic mobility, Techniques
of paper, gel, capillary electrophoresis, applications

UNIT –IV 08 Hours

Gas chromatography - Introduction, theory, instrumentation, derivatization,


temperature programming, advantages, disadvantages and applications
High performance liquid chromatography (HPLC)-Introduction, theory,
instrumentation, advantages and applications.

UNIT –V 07 Hours

Ion exchange chromatography- Introduction, classification, ion exchange resins,


properties, mechanism of ion exchange process, factors affecting ion exchange,
methodology and applications
Gel chromatography- Introduction, theory, instrumentation and applications
Affinity chromatography- Introduction, theory, instrumentation and applications

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP705P. INSTRUMENTAL METHODS OF ANALYSIS (Practical)


4 Hours/Week
1 Determination of absorption maxima and effect of solvents on absorption
maxima of organic compounds
2 Estimation of dextrose by colorimetry
3 Estimation of sulfanilamide by colorimetry
4 Simultaneous estimation of ibuprofen and paracetamol by UV spectroscopy
5 Assay of paracetamol by UV- Spectrophotometry
6 Estimation of quinine sulfate by fluorimetry
7 Study of quenching of fluorescence
8 Determination of sodium by flame photometry
9 Determination of potassium by flame photometry
10 Determination of chlorides and sulphates by nephelo turbidometry
11 Separation of amino acids by paper chromatography
12 Separation of sugars by thin layer chromatography
13 Separation of plant pigments by column chromatography
14 Demonstration experiment on HPLC
15 Demonstration experiment on Gas Chromatography

Recommended Books (Latest Editions)


1. Instrumental Methods of Chemical Analysis by B.K Sharma
2. Organic spectroscopy by Y.R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors
4. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel
5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
6. Organic Chemistry by I. L. Finar
7. Organic spectroscopy by William Kemp
8. Quantitative Analysis of Drugs by D. C. Garrett
9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
10. Spectrophotometric identification of Organic Compounds by Silverstein

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 702 T. INDUSTRIAL PHARMACYII (Theory)


45 Hours
Scope: This course is designed to impart fundamental knowledge on pharmaceutical
product development and translation from laboratory to market
Objectives: Upon completion of the course, the student shall be able to:
1. Know the process of pilot plant and scale up of pharmaceutical dosage forms
2. Understand the process of technology transfer from lab scale to commercial batch
3. Know different Laws and Acts that regulate pharmaceutical industry
4. Understand the approval process and regulatory requirements for drug products
Course Content:

UNIT-I 10 Hours
Pilot plant scale up techniques: General considerations - including significance of
personnel requirements, space requirements, raw materials, Pilot plant scale up
considerations for solids, liquid orals, semi solids and relevant documentation, SUPAC
guidelines, Introduction to platform technology

UNIT-II 10 Hours
Technology development and transfer: WHO guidelines for Technology Transfer(TT):
Terminology, Technology transfer protocol, Quality risk management, Transfer from R
& D to production (Process, packaging and cleaning), Granularity of TT Process (API,
excipients, finished products, packaging materials) Documentation, Premises and
equipments, qualification and validation, quality control, analytical method transfer,
Approved regulatory bodies and agencies, Commercialization - practical aspects and
problems (case studies), TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE /
SIDBI; TT related documentation - confidentiality agreement, licensing, MoUs,
legal issues

UNIT-III 10 Hours
Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatory
authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs
Professionals
Regulatory requirements for drug approval: Drug Development Teams, Non-Clinical
Drug Development, Pharmacology, Drug Metabolism and Toxicology, General
considerations of Investigational New Drug (IND) Application, Investigator’s Brochure
(IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research
Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA
Submissions, Management of Clinical Studies.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

UNIT-IV 08 Hours
Quality management systems: Quality management & Certifications: Concept of Quality,
Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of
Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems
standards, ISO 14000, NABL, GLP
UNIT-V 07 Hours
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO)
and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical
Product (COPP), Regulatory requirements and approval procedures for New Drugs.

Recommended Books: (Latest Editions)


1. Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th April available
at http,//[Link]/wiki/Regulatory_ Affairs.
2. International Regulatory Affairs Updates, 2005. available at
[Link]
3. Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide
for Prescription Drugs, Medical Devices, and Biologics’ Second Edition.
4. Regulatory Affairs brought by learning plus, inc. available at
http.//[Link]/[Link].

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 703T. PHARMACY PRACTICE (Theory)


45 Hours

Scope: In the changing scenario of pharmacy practice in India, for successful practice of
Hospital Pharmacy, the students are required to learn various skills like drug distribution,
drug information, and therapeutic drug monitoring for improved patient care. In community
pharmacy, students will be learning various skills such as dispensing of drugs, responding
to minor ailments by providing suitable safe medication, patient counselling for improved
patient care in the community set up.

Objectives: Upon completion of the course, the student shall be able to

1. know various drug distribution methods in a hospital


2. appreciate the pharmacy stores management and inventory control
3. monitor drug therapy of patient through medication chart review and clinical
review
4. obtain medication history interview and counsel the patients
5. identify drug related problems
6. detect and assess adverse drug reactions
7. interpret selected laboratory results (as monitoring parameters in therapeutics) of
specific disease states
8. know pharmaceutical care services
9. do patient counseling in community pharmacy;
10. appreciate the concept of Rational drug therapy.

Unit I: 10 Hours
a) Hospital and it’s organization
Definition, Classification of hospital- Primary, Secondary and Tertiary hospitals,
Classification based on clinical and non- clinical basis, Organization Structure of a
Hospital, and Medical staffs involved in the hospital and their functions.

b) Hospital pharmacy and its organization

Definition, functions of hospital pharmacy, Organization structure, Location, Layout


and staff requirements, and Responsibilities and functions of hospital pharmacists.

c) Adverse drug reaction


Classifications - Excessive pharmacological effects, secondary pharmacological effects,
idiosyncrasy, allergic drug reactions, genetically determined toxicity, toxicity following
sudden withdrawal of drugs, Drug interaction- beneficial interactions, adverse
interactions, and pharmacokinetic drug interactions, Methods for detecting

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

drug interactions, spontaneous case reports and record linkage studies, and Adverse drug
reaction reporting and management.

d) Community Pharmacy
Organization and structure of retail and wholesale drug store, types and design, Legal
requirements for establishment and maintenance of a drug store, Dispensing of
proprietary products, maintenance of records of retail and wholesale drug store.

Unit II: 10 Hours


a) Drug distribution system in a hospital
Dispensing of drugs to inpatients, types of drug distribution systems, charging policy
and labelling, Dispensing of drugs to ambulatory patients, and Dispensing of
controlled drugs.

b) Hospital formulary
Definition, contents of hospital formulary, Differentiation of hospital formulary and
Drug list, preparation and revision, and addition and deletion of drug from hospital
formulary.

c) Therapeutic drug monitoring


Need for Therapeutic Drug Monitoring, Factors to be considered during the
Therapeutic Drug Monitoring, and Indian scenario for Therapeutic Drug Monitoring.

d) Medication adherence
Causes of medication non-adherence, pharmacist role in the medication adherence,
and monitoring of patient medication adherence.

e) Patient medication history interview


Need for the patient medication history interview, medication interview forms.

f) Community pharmacy management


Financial, materials, staff, and infrastructure requirements.

Unit III: 10 Hours


a) Pharmacy and therapeutic committee
Organization, functions, Policies of the pharmacy and therapeutic committee in
including drugs into formulary, inpatient and outpatient prescription, automatic stop
order, and emergency drug list preparation.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

b) Drug information services


Drug and Poison information centre, Sources of drug information, Computerised
services, and storage and retrieval of information.

c) Patient counseling
Definition of patient counseling; steps involved in patient counseling, and Special
cases that require the pharmacist

d) Education and training program in the hospital


Role of pharmacist in the education and training program, Internal and external training
program, Services to the nursing homes/clinics, Code of ethics for community pharmacy,
and Role of pharmacist in the interdepartmental communication and community health
education.

e) Prescribed medication order and communication skills


Prescribed medication order- interpretation and legal requirements, and Communication
skills- communication with prescribers and patients.

Unit IV 8 Hours
a) Budget preparation and implementation
Budget preparation and implementation

b) Clinical Pharmacy
Introduction to Clinical Pharmacy, Concept of clinical pharmacy, functions and
responsibilities of clinical pharmacist, Drug therapy monitoring - medication chart
review, clinical review, pharmacist intervention, Ward round participation, Medication
history and Pharmaceutical care.
Dosing pattern and drug therapy based on Pharmacokinetic & disease pattern.

c) Over the counter (OTC) sales


Introduction and sale of over the counter, and Rational use of common over thecounter
medications.

Unit V 7 Hours
a) Drug store management and inventory control
Organisation of drug store, types of materials stocked and storage conditions, Purchase
and inventory control: principles, purchase procedure, purchase order, procurement and
stocking, Economic order quantity, Reorder quantity level, and Methods used for the
analysis of the drug expenditure

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

b) Investigational use of drugs


Description, principles involved, classification, control, identification, role of hospital
pharmacist, advisory committee.

c) Interpretation of Clinical Laboratory Tests


Blood chemistry, hematology, and urinalysis

Recommended Books (Latest Edition):

1. Merchant S.H. and Dr. [Link]. A textbook of hospital pharmacy, 4th ed.
Ahmadabad: B.S. Shah Prakakshan; 2001.
2. Parthasarathi G, Karin Nyfort-Hansen, Milap C Nahata. A textbook of Clinical
Pharmacy Practice- essential concepts and skills, 1st ed. Chennai: Orient
Longman Private Limited; 2004.
3. William E. Hassan. Hospital pharmacy, 5th ed. Philadelphia: Lea & Febiger;
1986.
4. Tipnis Bajaj. Hospital Pharmacy, 1st ed. Maharashtra: Career Publications; 2008.
5. Scott LT. Basic skills in interpreting laboratory data, 4thed. American Society of
Health System Pharmacists Inc; 2009.
6. Parmar N.S. Health Education and Community Pharmacy, 18th ed. India: CBS
Publishers & Distributers; 2008.

Journals:

1. Therapeutic drug monitoring. ISSN: 0163-4356


2. Journal of pharmacy practice. ISSN : 0974-8326
3. American journal of health system pharmacy. ISSN: 1535-2900 (online)
4. Pharmacy times (Monthly magazine)

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 704T: NOVEL DRUG DELIVERY SYSTEMS (Theory)


45 Hours
Scope: This subject is designed to impart basic knowledge on the area of novel drug
delivery systems.
Objectives: Upon completion of the course student shall be able
1. To understand various approaches for development of novel drug delivery systems.
2. To understand the criteria for selection of drugs and polymers for the development of
Novel drug delivery systems, their formulation and evaluation
Course content:
Unit-I 10 Hours
Controlled drug delivery systems: Introduction, terminology/definitions and rationale,
advantages, disadvantages, selection of drug [Link] to design controlled
release formulations based on diffusion, dissolution and ion exchange principles.
Physicochemical and biological properties of drugs relevant to controlled release
formulations
Polymers: Introduction, classification, properties, advantages and application of polymers
in formulation of controlled release drug delivery systems.
Unit-II 10 Hours
Microencapsulation: Definition, advantages and disadvantages, microspheres
/microcapsules, microparticles, methods of microencapsulation, applications
Mucosal Drug Delivery system: Introduction, Principles of bioadhesion / mucoadhesion,
concepts, advantages and disadvantages, transmucosal permeability and formulation
considerations of buccal delivery systems
Implantable Drug Delivery Systems:Introduction, advantages and disadvantages,concept
of implantsand osmotic pump
Unit-III 10 Hours
Transdermal Drug Delivery Systems: Introduction, Permeation through skin, factors
affecting permeation, permeation enhancers, basic components of TDDS, formulation
approaches
Gastroretentive drug delivery systems: Introduction, advantages, disadvantages,
approaches for GRDDS – Floating, high density systems, inflatable and gastroadhesive
systems and their applications
Nasopulmonary drug delivery system: Introduction to Nasal and Pulmonary routes of
drug delivery, Formulation of Inhalers (dry powder and metered dose), nasal sprays,
nebulizers

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Unit-IV 08 Hours
Targeted drug Delivery: Concepts and approaches advantages and disadvantages,
introduction to liposomes, niosomes, nanoparticles, monoclonal antibodies and their
applications

Unit-V 07 Hours
Ocular Drug Delivery Systems: Introduction, intra ocular barriers and methods to
overcome –Preliminary study, ocular formulations and ocuserts
Intrauterine Drug Delivery Systems: Introduction, advantages and disadvantages,
development of intra uterine devices (IUDs) and applications

Recommended Books: (Latest Editions)


1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded,Marcel
Dekker, Inc., New York, 1992.
2. Robinson, J. R., Lee V. H. L, Controlled Drug Delivery Systems, Marcel Dekker,Inc.,
New York, 1992.
3. Encyclopedia of Controlled Delivery. Edith Mathiowitz, Published by Wiley
Interscience Publication, John Wiley and Sons, Inc, New York. Chichester/Weinheim
4. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors,New
Delhi, First edition 1997 (reprint in 2001).
5. S.P. Vyas and R.K. Khar, Controlled Drug Delivery -concepts and advances,
Vallabh Prakashan, New Delhi, First edition 2002.
Journals
1. Indian Journal of Pharmaceutical Sciences (IPA)
2. Indian Drugs (IDMA)
3. Journal of Controlled Release (Elsevier Sciences)
4. Drug Development and Industrial Pharmacy (Marcel & Decker)
5. International Journal of Pharmaceutics (Elsevier Sciences)

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY


(Formerly Uttarakhand Technical University, Dehradun Established by Uttarakhand State Govt. wide Act no. 415 of 2005)
Suddhowala, PO-Chandanwadi, Premnagar, Dehradun, Uttarakhand (Website- [Link])

SYLLABUS
For

B. PHARMA
4th Year (VIII SEMESTER)

Effective From – Session 2025-26

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

SEMESTER VIII

Evaluation pattern

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP801T. BIOSTATISITCS AND RESEARCH METHODOLOGY (Theory)

45 Hours

Scope: To understand the applications of Biostatics in Pharmacy. This subject deals with
descriptive statistics, Graphics, Correlation, Regression, logistic regression Probability
theory, Sampling technique, Parametric tests, Non Parametric tests, ANOVA, Introduction
to Design of Experiments, Phases of Clinical trials and Observational and Experimental
studies, SPSS, R and MINITAB statistical software’s, analyzing the statistical data using
Excel.

Objectives: Upon completion of the course the student shall be able to


• Know the operation of M.S. Excel, SPSS, R and MINITAB®, DoE (Design of
Experiment)
• Know the various statistical techniques to solve statistical problems
• Appreciate statistical techniques in solving the problems.

Course content:
Unit-I 10 Hours
Introduction: Statistics, Biostatistics, Frequency distribution
Measures of central tendency: Mean, Median, Mode- Pharmaceutical examples
Measures of dispersion: Dispersion, Range, standard deviation, Pharmaceutical
problems
Correlation: Definition, Karl Pearson’s coefficient of correlation, Multiple correlation -
Pharmaceuticals examples

Unit-II 10 Hours
Regression: Curve fitting by the method of least squares, fitting the lines y= a + bx and x
= a + by, Multiple regression, standard error of regression– Pharmaceutical Examples
Probability:Definition of probability, Binomial distribution, Normal distribution,
Poisson’s distribution, properties - problems
Sample, Population, large sample, small sample, Null hypothesis, alternative hypothesis,
sampling, essence of sampling, types of sampling, Error-I type, Error-II type, Standard
error of mean (SEM) - Pharmaceutical examples
Parametric test: t-test(Sample, Pooled or Unpaired and Paired) , ANOVA, (One way
and Two way), Least Significance difference

Unit-III 10 Hours
Non Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney U test, Kruskal-Wallis
test, Friedman Test

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Introduction to Research: Need for research, Need for design of Experiments,


Experiential Design Technique, plagiarism
Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot, Counter Plot graph
Designing the methodology: Sample size determination and Power of a study, Report
writing and presentation of data, Protocol, Cohorts studies, Observational studies,
Experimental studies, Designing clinical trial, various phases.

Unit-IV 8 Hours
Blocking and confounding system for Two-level factorials
Regression modeling: Hypothesis testing in Simple and Multiple regressionmodels
Introduction to Practical components of Industrial and Clinical Trials Problems:
Statistical Analysis Using Excel, SPSS, MINITAB®, DESIGN OF EXPERIMENTS, R -
Online Statistical Software’s to Industrial and Clinical trial approach

Unit-V 7Hours
Design and Analysis of experiments:
Factorial Design: Definition, 22, 23design. Advantage of factorial design
Response Surface methodology: Central composite design, Historical design,
Optimization Techniques

Recommended Books (Latest edition):

1. Pharmaceutical statistics- Practical and clinical applications, Sanford Bolton,


publisher Marcel Dekker Inc. NewYork.
2. Fundamental of Statistics – Himalaya Publishing House- [Link]
3. Design and Analysis of Experiments –PHI Learning Private Limited, R.
Pannerselvam,
4 Design and Analysis of Experiments – Wiley Students Edition,Douglas and C.
Montgomery

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 802T SOCIAL AND PREVENTIVE PHARMACY

Hours: 45

Scope:

The purpose of this course is to introduce to students a number of health issues and their
challenges. This course also introduced a number of national health programmes. The roles
of the pharmacist in these contexts are also discussed.

Objectives:
After the successful completion of this course, the student shall be able to:
• Acquire high consciousness/realization of current issuesrelated to health and
pharmaceutical problems within the country and worldwide.
• Have a critical way of thinking based on current healthcare development.
• Evaluate alternative ways of solving problems related tohealth and
pharmaceutical issues
Course content:

Unit I: 10 Hours
Concept of health and disease: Definition, concepts and evaluation of public health.
Understanding the concept of prevention and control of disease, social causes of diseases
and social problems of the sick.

Social and health education: Food in relation to nutrition and health, Balanced diet,
Nutritional deficiencies, Vitamin deficiencies, Malnutrition and its prevention.

Sociology and health: Socio cultural factors related to health and disease, Impact of
urbanization on health and disease, Poverty and health

Hygiene and health: personal hygiene and health care; avoidable habits

Unit II: 10 Hours


Preventive medicine: General principles of prevention and control of diseases such as
cholera, SARS, Ebola virus, influenza, acute respiratory infections, malaria, chicken
guinea, dengue, lymphatic filariasis, pneumonia, hypertension, diabetes mellitus, cancer,
drug addiction-drug substance abuse

Unit III: 10 Hours


National health programs, its objectives, functioning and outcome of the following:
HIV AND AIDS control programme, TB, Integrated disease surveillance program (IDSP),
National leprosy control programme, National mental health program, National

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

programme for prevention and control of deafness, Universal immunization programme,


National programme for control of blindness, Pulse polio programme.

Unit IV: 08 Hours


National health intervention programme for mother and child, National family welfare
programme, National tobacco control programme, National Malaria Prevention Program,
National programme for the health care for the elderly, Social health programme; role of
WHO in Indian national program

Unit V: 07 Hours
Community services in rural, urban and school health: Functions of PHC, Improvement
in rural sanitation, national urban health mission, Health promotion and education in
school.

Recommended Books (Latest edition):

1. Short Textbook of Preventive and Social Medicine, Prabhakara GN, 2nd Edition,
2010, ISBN: 9789380704104, JAYPEE Publications
2. Textbook of Preventive and Social Medicine (Mahajan and Gupta), Edited by Roy
Rabindra Nath, Saha Indranil, 4th Edition, 2013, ISBN: 9789350901878, JAYPEE
Publications
3. Review of Preventive and Social Medicine (Including Biostatistics), Jain Vivek, 6th
Edition, 2014, ISBN: 9789351522331, JAYPEE Publications
4. Essentials of Community Medicine—A Practical Approach, Hiremath Lalita D,
Hiremath Dhananjaya A, 2nd Edition, 2012, ISBN: 9789350250440, JAYPEE
Publications
5. Park Textbook of Preventive and Social Medicine, K Park, 21st Edition, 2011,ISBN-
14: 9788190128285, BANARSIDAS BHANOT PUBLISHERS.
6. Community Pharmacy Practice, Ramesh Adepu, BSP publishers, Hyderabad

Recommended Journals:

1. Research in Social and Administrative Pharmacy, Elsevier, Ireland

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP803ET. PHARMA MARKETING MANAGEMENT (Theory)

45 Hours
Scope:
The pharmaceutical industry not only needs highly qualified researchers, chemists and,
technical people, but also requires skilled managers who can take the industry forward
by managing and taking the complex decisions which are imperative for the growth of the
industry. The Knowledge and Know-how of marketing management groom the people for
taking a challenging role in Sales and Product management.

Course Objective: The course aims to provide an understanding of marketing concepts and
techniques and their applications in the pharmaceutical industry.

Unit I 10 Hours
Marketing:
Definition, general concepts and scope of marketing; Distinction between marketing &
selling; Marketing environment; Industry and competitive analysis; Analyzing consumer
buying behavior; industrial buying behavior.

Pharmaceutical market:
Quantitative and qualitative aspects; size and composition of the market; demographic
descriptions and socio-psychological characteristics of the consumer; market
segmentation& [Link] profile; Motivation and prescribing habits of the
physician; patients' choice of physician and retail [Link] the Market;Roleof
market research.

Unit II 10 Hours
Product decision:
Classification, product line and product mix decisions, product life cycle,product
portfolio analysis; product positioning; New product decisions; Product branding,
packaging and labeling decisions, Product management in pharmaceutical industry.

Unit III 10 Hours


Promotion:
Methods, determinants of promotional mix, promotional budget; An overview of personal
selling, advertising, direct mail, journals, sampling, retailing, medical exhibition, public
relations, online promotional techniques for OTC Products.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Unit IV 10 Hours
Pharmaceutical marketing channels:
Designing channel, channel members, selecting the appropriate channel, conflict in
channels, physical distribution management: Strategic importance, tasks in physical
distribution management.

Professional sales representative (PSR):


Duties of PSR, purpose of detailing, selection and training, supervising, norms for
customer calls, motivating, evaluating, compensation and future prospects of the PSR.

Unit V 10 Hours
Pricing:
Meaning, importance, objectives, determinants of price; pricing methods and strategies,
issues in price management in pharmaceutical industry. An overview of DPCO (Drug
Price Control Order)and NPPA (National Pharmaceutical Pricing Authority).

Emerging concepts in marketing:


Vertical & Horizontal Marketing; RuralMarketing; Consumerism; Industrial Marketing;
Global Marketing.

Recommended Books: (Latest Editions)


1. Philip Kotler and Kevin Lane Keller: Marketing Management, Prentice Hall of India,
New Delhi
2. Walker, Boyd and Larreche : Marketing Strategy- Planning and Implementation, Tata
MC GrawHill, New Delhi.
3. Dhruv Grewal and Michael Levy: Marketing, Tata MC Graw Hill
4. Arun Kumar and N Menakshi: Marketing Management, Vikas Publishing, India
5. Rajan Saxena: Marketing Management; Tata MC Graw-Hill (India Edition)
6. Ramaswamy, U.S & Nanakamari, S: Marketing Managemnt:Global Perspective,
IndianContext,Macmilan India, New Delhi.
7. Shanker, Ravi: Service Marketing, Excell Books, New Delhi
8. Subba Rao Changanti, Pharmaceutical Marketing in India (GIFT – Excel series) Excel
Publications.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)

45Hours

Scope: This course is designed to impart the fundamental knowledge on the regulatory
requirements for approval of new drugs, and drug products in regulated markets of India
& other countries like US, EU, Japan, Australia,UK etc. It prepares the students to learn
in detail on the regulatory requirements, documentation requirements, and registration
procedures for marketing the drug products.

Objectives: Upon completion of the subject student shall be able to;


1. Know about the process of drug discovery and development
2. Know the regulatory authorities and agencies governing the manufacture and sale
of pharmaceuticals
3. Know the regulatory approval process and their registration in Indian and
international markets
Course content:
Unit I 10Hours

New Drug Discovery and development


Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical
activities, clinical studies, Innovator and generics, Concept of generics, Generic drug
product development.

Unit II 10Hours

Regulatory Approval Process


Approval processes and timelines involved in Investigational New Drug (IND), New Drug
Application (NDA), Abbreviated New Drug Application (ANDA). Changes to an approved
NDA / ANDA.
Regulatory authorities and agencies
Overview of regulatory authorities of India, United States, European Union, Australia,
Japan, Canada (Organization structure and types of applications)

Unit III 10Hours

Registration of Indian drug product in overseas market


Procedure for export of pharmaceutical products, Technical documentation, Drug Master
Files (DMF), Common Technical Document (CTD), electronic Common Technical

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Document (eCTD), ASEAN Common Technical Document (ACTD)research.

Unit IV 08Hours

Clinical trials
Developing clinical trial protocols, Institutional Review Board / Independent Ethics
committee - formation and working procedures, Informed consent process and procedures,
GCP obligations of Investigators, sponsors & Monitors, Managing and Monitoring clinical
trials, Pharmacovigilance - safety monitoring in clinical trials

Unit V 07Hours

Regulatory Concepts
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book,
Federal Register, Code of Federal Regulatory, Purple book

Recommended books (Latest edition):


1. Drug Regulatory Affairs by Sachin Itkar, Dr. N.S. Vyawahare, Nirali Prakashan.
2. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and
Robert P. Martin, Drugs and the Pharmaceutical Sciences,Vol.185. Informa Health
care Publishers.
3. New Drug Approval Process: Accelerating Global Registrations By Richard A
Guarino, MD, 5th edition, Drugs and the Pharmaceutical Sciences,Vol.190.
4. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley &
Sons. Inc.
5. FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and
biologics /edited by Douglas J. Pisano, David Mantus.
6. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and
Isader Kaufer, Marcel Dekker series, Vol.143
7. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance
By Fay A. Rozovsky and Rodney K. Adams
8. Principles and Practices of Clinical Research, Second Edition Edited by John I.
Gallin and Frederick P. Ognibene
9. Drugs: From Discovery to Approval, Second Edition By Rick Ng

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 805T: PHARMACOVIGILANCE (Theory)


45 hours

Scope: This paper will provide an opportunity for the student to learn about development of
pharmacovigilance as a science, basic terminologies used in pharmacovigilance, global scenarioof
Pharmacovigilance, train students on establishing pharmacovigilance programme in an
organization, various methods that can be used to generate safety data and signal detection. This
paper also develops the skills of classifying drugs, diseases and adverse drug reactions.

Objectives:

At completion of this paper it is expected that students will be able to (know, do, and
appreciate):

1. Why drug safety monitoring is important?


2. History and development of pharmacovigilance
3. National and international scenario of pharmacovigilance
4. Dictionaries, coding and terminologies used in pharmacovigilance
5. Detection of new adverse drug reactions and their assessment
6. International standards for classification of diseases and drugs
7. Adverse drug reaction reporting systems and communication in pharmacovigilance
8. Methods to generate safety data during pre clinical, clinical and post approval phases of
drugs’ life cycle
9. Drug safety evaluation in paediatrics, geriatrics, pregnancy and lactation
10. Pharmacovigilance Program of India (PvPI) requirement for ADR reporting in India
11. ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning
12. CIOMS requirements for ADR reporting
13. Writing case narratives of adverse events and their quality.

Course Content

Unit I 10 Hours
Introduction to Pharmacovigilance
History and development of Pharmacovigilance
Importance of safety monitoring of Medicine
WHO international drug monitoring programme
Pharmacovigilance Program of India(PvPI)
Introduction to adverse drug reactions
Definitions and classification of ADRs
Detection and reporting
Methods in Causality assessment
Severity and seriousness assessment
Predictability and preventability assessment
Management of adverse drug reactions

Basic terminologies used in pharmacovigilance


Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Terminologies of adverse medication related events


Regulatory terminologies

Unit II 10 hours
Drug and disease classification
Anatomical, therapeutic and chemical classification of drugs
International classification of diseases
Daily defined doses
International Non proprietary Names for drugs
Drug dictionaries and coding in pharmacovigilance
WHO adverse reaction terminologies
MedDRA and Standardised MedDRA queries
WHO drug dictionary
Eudravigilance medicinal product dictionary
Information resources in pharmacovigilance
Basic drug information resources
Specialised resources for ADRs
Establishing pharmacovigilance programme
Establishing in a hospital
Establishment & operation of drug safety department in industry
Contract Research Organisations (CROs)
Establishing a national programme

Unit III 10 Hours


Vaccine safety surveillance
Vaccine Pharmacovigilance
Vaccination failure
Adverse events following immunization
Pharmacovigilance methods
Passive surveillance – Spontaneous reports and case series
Stimulated reporting
Active surveillance – Sentinel sites, drug event monitoring and registries
Comparative observational studies – Cross sectional study, case control study and
cohort study
Targeted clinical investigations
Communication in pharmacovigilance
Effective communication in Pharmacovigilance
Communication in Drug Safety Crisis management
Communicating with Regulatory Agencies, Business Partners, Healthcare facilities &
Media

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Unit IV 8 Hours
Safety data generation
Pre clinical phase
Clinical phase
Post approval phase (PMS)
ICH Guidelines for Pharmacovigilance
Organization and objectives of ICH
Expedited reporting
Individual case safety reports
Periodic safety update reports
Post approval expedited reporting
Pharmacovigilance planning
Good clinical practice in pharmacovigilance studies
Unit V 7 hours
Pharmacogenomics of adverse drug reactions
Genetics related ADR with example focusing PK parameters.
Drug safety evaluation in special population
Paediatrics
Pregnancy and lactation
Geriatrics
CIOMS
CIOMS Working Groups
CIOMS Form
CDSCO (India) and Pharmacovigilance
D&C Act and Schedule Y
Differences in Indian and global pharmacovigilance requirements
Recommended Books (Latest edition):
1. Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers.
2. Practical Drug Safety from A to Z By Barton Cobert, Pierre Biron, Jones and
Bartlett Publishers.
3. Mann's Pharmacovigilance:Elizabeth B. Andrews, Nicholas, Wiley Publishers.
4. Stephens' Detection of New Adverse Drug Reactions: John Talbot, Patrick Walle,
Wiley Publishers.
5. An Introduction to Pharmacovigilance: Patrick Waller,Wiley Publishers.
6. Cobert's Manual of Drug Safety and Pharmacovigilance: Barton Cobert,Jones&
Bartlett Publishers.
7. Textbook of Pharmacoepidemiolog edited by Brian L. Strom, Stephen E Kimmel,
Sean Hennessy,Wiley Publishers.
8. A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills:G.
Parthasarathi, Karin NyfortHansen,Milap C. Nahata
9. National Formulary of India
10. Text Book of Medicine by Yashpal Munjal

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

11. Text book of Pharmacovigilance: concept and practice by GP Mohanta and PK


Manna
12. [Link]
3=7297
13. [Link]
14. [Link]
15. [Link]
16. [Link]
17. [Link]

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 806 ET. QUALITY CONTROL AND STANDARDIZATION OF HERBALS


(Theory)

Scope: In this subject the student learns about the various methods and guidelines for
evaluation and standardization of herbs and herbal drugs. The subject also provides an
opportunity for the student to learn cGMP, GAP and GLP in traditional system of
medicines.

Objectives: Upon completion of the subject student shall be able to;


1. know WHO guidelines for quality control of herbal drugs
2. know Quality assurance in herbal drug industry
3. know the regulatory approval process and their registration in Indian and
international markets
4. appreciate EU and ICH guidelines for quality control of herbal drugs

Unit I 10 hours
Basic tests for drugs – Pharmaceutical substances, Medicinal plants materials and dosage
forms
WHO guidelines for quality control of herbal drugs.
Evaluation of commercial crude drugs intended for use

Unit II 10 hours
Quality assurance in herbal drug industry of cGMP, GAP, GMP and GLP in
traditional system of medicine.

WHO Guidelines on current good manufacturing Practices (cGMP) for Herbal Medicines
WHO Guidelines on GACP for Medicinal Plants.

Unit III 10 hours


EU and ICH guidelines for quality control of herbal drugs.
Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines

Unit IV 08 hours
Stability testing of herbal [Link] of various chromatographic techniques
in standardization of herbal products.
Preparation of documents for new drug application and export registration
GMP requirements and Drugs & Cosmetics Act provisions.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Unit V 07 hours
Regulatory requirements for herbal medicines.
WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems
Comparison of various Herbal Pharmacopoeias.
Role of chemical and biological markers in standardization of herbal products

Recommended Books: (Latest Editions


1. Pharmacognosy by Trease and Evans
2. Pharmacognosy by Kokate, Purohit and Gokhale
3. Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier
Pub., 2006.
4. Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002.
5. EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional Medicinal
Products,
6. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of
Botanicals. Business Horizons Publishers, New Delhi, India, 2002.
7. Shinde M.V., Dhalwal K., Potdar K., Mahadik K. Application of quality control
principles to herbal drugs. International Journal of Phytomedicine 1(2009); p. 4-8.
8. WHO. Quality Control Methods for Medicinal Plant Materials, World Health
Organization, Geneva, 1998. WHO. Guidelines for the Appropriate Use of Herbal
Medicines. WHO Regional Publications, Western Pacific Series No 3, WHO
Regional office for the Western Pacific, Manila, 1998.
9. WHO. The International Pharmacopeia, Vol. 2: Quality Specifications, 3rd edn.
World Health Organization, Geneva, 1981.
10. WHO. Quality Control Methods for Medicinal Plant Materials. World Health
Organization, Geneva, 1999.
11. WHO. WHO Global Atlas of Traditional, Complementary and Alternative
Medicine. 2 vol. set. Vol. 1 contains text and Vol. 2, maps. World Health
Organization, Geneva, 2005.
12. WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for
Medicinal Plants. World Health Organization, Geneva, 2004.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 807 ET. COMPUTER AIDED DRUG DESIGN (Theory)


45 Hours
Scope: This subject is designed to provide detailed knowledge of rational drug design
process and various techniques used in rational drug design process.
Objectives: Upon completion of the course, the student shall be able to understand
• Design and discovery of lead molecules
• The role of drug design in drug discovery process
• The concept of QSAR and docking
• Various strategies to develop new drug like molecules.
• The design of new drug molecules using molecular modeling software

Course Content:
UNIT-I 10 Hours
Introduction to Drug Discovery and Development
Stages of drug discovery and development
Lead discovery and Analog Based Drug Design
Rational approaches to lead discovery based on traditional medicine,
Random screening, Non-random screening, serendipitous drug discovery,
lead discovery based on drug metabolism, lead discovery based on clinical
observation.
Analog Based Drug Design:Bioisosterism, Classification, Bioisosteric
replacement. Any three case studies

UNIT-II 10 Hours
Quantitative Structure Activity Relationship (QSAR)
SAR versus QSAR, History and development of QSAR, Types of
physicochemical parameters, experimental and theoretical approaches for
the determination of physicochemical parameters such as Partition
coefficient, Hammet’s substituent constant and Tafts steric constant.
Hansch analysis, Free Wilson analysis, 3D-QSAR approaches like COMFA
and COMSIA.

UNIT-III 10 Hours
Molecular Modeling and virtual screening techniques
Virtual Screening techniques: Drug likeness screening, Concept of
pharmacophore mapping and pharmacophore based Screening,
Molecular docking: Rigid docking, flexible docking, manual docking,
Docking based screening. De novo drug design.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

UNIT-IV 08 Hours
Informatics & Methods in drug design
Introduction to Bioinformatics, chemoinformatics. ADME databases,
chemical, biochemical and pharmaceutical databases.

UNIT-V 07 Hours
Molecular Modeling: Introduction to molecular mechanics and quantum
[Link] Minimization methods and Conformational Analysis,
global conformational minima determination.

Recommended Books (Latest Editions)

1. Robert GCK, ed., “Drug Action at the Molecular Level” University Prak Press Baltimore.
2. Martin YC. “Quantitative Drug Design” Dekker, New York.
3. Delgado JN, Remers WA eds “Wilson & Gisvolds’s Text Book of Organic
Medicinal & Pharmaceutical Chemistry” Lippincott, New York.
4. Foye WO “Principles of Medicinal chemistry ‘Lea & Febiger.
5. Koro lkovas A, Burckhalter JH. “Essentials of Medicinal Chemistry” Wiley
Interscience.
6. Wolf ME, ed “The Basis of Medicinal Chemistry, Burger’s Medicinal Chemistry”
John Wiley & Sons, New York.
7. Patrick Graham, L., An Introduction to Medicinal Chemistry, Oxford University
Press.
8. Smith HJ, Williams H, eds, “Introduction to the principles of Drug Design”
Wright Boston.
9. Silverman R.B. “The organic Chemistry of Drug Design and Drug Action”
Academic Press New York.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP808ET: CELL AND MOLECULAR BIOLOGY (Elective subject)


45 Hours

Scope:
Cell biology is a branch of biology that studies cells – their physiological properties,
their structure, the organelles they contain, interactions with their environment, their
life cycle, division, death and cell function.
This is done both on a microscopic and molecular level.
Cell biology research encompasses both the great diversity of single-celled
organisms like bacteria and protozoa, as well as the many specialized cells in multi-
cellular organismssuch as humans, plants, and sponges.

Objectives: Upon completion of the subject student shall be able to;


Summarize cell and molecular biology history.
Summarize cellular functioning and composition.
Describe the chemical foundations of cell biology.
Summarize the DNA properties of cell biology.
Describe protein structure and function.
Describe cellular membrane structure and function.
Describe basic molecular genetic mechanisms.
Summarize the Cell Cycle
Course content:
Unit I 10Hours
a) Cell and Molecular Biology: Definitions theory and basics and Applications.
b) Cell and Molecular Biology: History and Summation.
c) Properties of cells and cell membrane.
d) Prokaryotic versus Eukaryotic
e) Cellular Reproduction
f) Chemical Foundations – an Introduction and Reactions (Types)

Unit II 10 Hours
a) DNA and the Flow of Molecular Information
b) DNA Functioning
c) DNA and RNA
d) Types of RNA
e) Transcription and Translation

Unit III 10 Hours


a) Proteins: Defined and Amino Acids
b) Protein Structure

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

c) Regularities in Protein Pathways


d) Cellular Processes
e) Positive Control and significance of Protein Synthesis

Unit IV 08 Hours
a) Science of Genetics
b) Transgenics and Genomic Analysis
c) Cell Cycle analysis
d) Mitosis and Meiosis
e) Cellular Activities and Checkpoints
Unit V 07 Hours
a) Cell Signals: Introduction
b) Receptors for Cell Signals
c) Signaling Pathways: Overview
d) Misregulation of Signaling Pathways
e) Protein-Kinases: Functioning
Recommended Books (latest edition):
1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific
publications, Oxford London.
2. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers &
Distributors, Delhi.
3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.
4. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.
5. Rose: Industrial Microbiology.
6. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan
7. Cooper and Gunn’s: Tutorial Pharmacy, CBS Publisher and Distribution.
8. Peppler: Microbial Technology.
9. Edward: Fundamentals of Microbiology.
10. [Link]: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi
11. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly
company
12. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and
Applications of RecombinantDNA: ASM Press Washington D.C.
13. RA Goldshy et. al., : Kuby Immunology.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP809ET. COSMETIC SCIENCE(Theory)


45Hours

UNIT I 10Hours
Classification of cosmetic and cosmeceutical products
Definition of cosmetics as per Indian and EU regulations, Evolution of cosmeceuticals
from cosmetics, cosmetics as quasi and OTC drugs
Cosmetic excipients: Surfactants, rheology modifiers, humectants, emollients,
preservatives. Classification and application
Skin: Basic structure and function of skin.
Hair: Basic structure of hair. Hair growth cycle.
Oral Cavity: Common problem associated with teeth and gums.

UNIT II 10 Hours
Principles of formulation and building blocks of skin care products:
Face wash,
Moisturizing cream, Cold Cream, Vanishing cream and their advantages and
[Link] of these products in formulation of cosmecuticals.
Antiperspants & deodorants- Actives & mechanism of action.
Principles of formulation and building blocks of Hair care products:
Conditioning shampoo, Hair conditioner,anti-dandruff shampoo.
Hair oils.
Chemistry and formulation of Para-phylene diamine based hair dye.
Principles of formulation and building blocks of oral care products:
Toothpaste for bleeding gums, sensitive teeth. Teeth whitening, Mouthwash.

UNIT III 10 Hours


Sun protection, Classification of Sunscreens and SPF.
Role of herbs in cosmetics:
Skin Care: Aloe and turmeric
Hair care: Henna and amla.
Oral care: Neem and clove
Analytical cosmetics: BIS specification and analytical methods for shampoo, skin-
cream and toothpaste.

UNIT IV 08 Hours.
Principles of Cosmetic Evaluation:Principles of sebumeter, corneometer. Measurement
of TEWL, Skin Color, Hair tensile strength, Hair combing properties
Soaps,and syndet bars. Evolution and skin benfits.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

UNIT V 07 Hours
Oily and dry skin, causes leading to dry skin, skin moisturisation. Basic understanding of
the terms Comedogenic, dermatitis.
Cosmetic problems associated with Hair and scalp: Dandruff, Hair fall causes
Cosmetic problems associated with skin: blemishes, wrinkles, acne, prickly heat and
body odor.
Antiperspirants and Deodorants- Actives and mechanism of action

References
1) Harry’s Cosmeticology, Wilkinson, Moore, Seventh Edition, George Godwin.
2) Cosmetics – Formulations, Manufacturing and Quality Control, P.P. Sharma, 4th
Edition, Vandana Publications Pvt. Ltd., Delhi.
3) Text book of cosmelicology by Sanju Nanda & Roop K. Khar, Tata Publishers.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP810 ET. PHARMACOLOGICAL SCREENING METHODS

45 Hours

Scope:This subject is designed to impart the basic knowledge of preclinical studies in


experimental animals including design, conduct and interpretations of results.

Objectives
Upon completion of the course the student shall be able to,
• Appreciate the applications of various commonly used laboratory animals.
• Appreciate and demonstrate the various screening methods used in preclinical
research
• Appreciate and demonstrate the importance of biostatistics and researchmethodology
• Design and execute a research hypothesis independently

Unit –I 08 Hours
Laboratory Animals:
Study of CPCSEA and OECD guidelines for maintenance, breeding and
conduct of experiments on laboratory animals, Common lab animals:
Description and applications of different species and strainsof animals.
Popular transgenic and mutant animals.
Techniques for collection of blood and common routes of drug
administration in laboratory animals, Techniques of blood collection and
euthanasia.
Unit –II 10 Hours
Preclinical screening models
a. Introduction: Dose selection, calculation and conversions,
preparation of drug solution/suspensions, grouping of animals and
importance of sham negative and positive control groups. Rationale
for selection of animal species and sex for the study.
b. Study of screening animal models for
Diuretics, nootropics, anti-Parkinson’s,antiasthmatics,
Preclinical screening models: for CNS activity- analgesic,
antipyretic,anti-inflammatory, general anaesthetics, sedative and
hypnotics, antipsychotic, antidepressant, antiepileptic,
antiparkinsonism, alzheimer’s disease

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Unit –III
Preclinical screening models: for ANS activity, sympathomimetics,
sympatholytics, parasympathomimetics, parasympatholytics, skeletal
muscle relaxants, drugs acting on eye, local anaethetics
Unit –IV
Preclinical screening models: for CVS activity- antihypertensives,
diuretics, antiarrhythmic, antidyslepidemic, anti aggregatory,
coagulants, and anticoagulants
Preclinical screening models for other important drugs like antiulcer,
antidiabetic, anticancer and antiasthmatics.
Research methodology and Bio-statistics 05 Hours
Selection of research topic, review of literature, research hypothesis
and study design
Pre-clinical data analysis and interpretation using Students ‘t’ test
and One-way ANOVA. Graphical representation of data
Recommended Books (latest edition):

1. Fundamentals of experimental Pharmacology-by [Link]


2. Hand book of Experimental [Link]
3. CPCSEA guidelines for laboratory animal facility.
4. Drug discovery and Evaluation by Vogel H.G.
5. Drug Screening Methods by Suresh Kumar Gupta and S. K. Gupta
6. Introduction to biostatistics and research methods by PSS Sundar Rao and J
Richard

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 811 ET. ADVANCED INSTRUMENTATION TECHNIQUES


45 Hours

Scope: This subject deals with the application of instrumental methods in qualitative and
quantitative analysis of drugs. This subject is designed to impart advanced knowledge on
the principles and instrumentation of spectroscopic and chromatographic hyphenated
techniques. This also emphasizes on theoretical and practical knowledge on modern
analytical instruments that are used for drug testing.

Objectives:Upon completion of the course the student shall be able to


• understand the advanced instruments used and its applications in drug analysis
• understand the chromatographic separation and analysis of drugs.
• understand the calibration of various analytical instruments
• know analysis of drugs using various analytical instruments.

Course Content:
UNIT-I 10 Hours
Nuclear Magnetic Resonance spectroscopy
Principles of H-NMR and C-NMR, chemical shift, factors affecting chemical
shift, coupling constant, Spin - spin coupling, relaxation, instrumentation and
applications
Mass Spectrometry- Principles, Fragmentation, Ionization techniques –
Electron impact, chemical ionization, MALDI, FAB, Analyzers-Time of flight
and Quadrupole, instrumentation, applications

UNIT-II 10 Hours
Thermal Methods of Analysis: Principles, instrumentation and applications
of ThermogravimetricAnalysis (TGA), Differential Thermal Analysis (DTA),
Differential Scanning Calorimetry (DSC)
X- Ray Diffraction Methods : Origin of X-rays, basic aspects of crystals, X-
ray
Crystallography, rotating crystal technique, single crystal diffraction,powder
diffraction, structural elucidation and applications.

UNIT-III 10 Hours
Calibration and validation-as per ICH and USFDA guidelines
Calibration of following Instruments
Electronic balance, UV-Visible spectrophotometer, IR spectrophotometer,
Fluorimeter, Flame Photometer, HPLC and GC

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

UNIT-IV 08 Hours
Radio immune assay:Importance, various components, Principle, different
methods, Limitation and Applications of Radio immuno assay
Extraction techniques:General principle and procedure involved in the solid
phase extraction and liquid-liquid extraction

UNIT-V 07 Hours
Hyphenated techniques-LC-MS/MS, GC-MS/MS, HPTLC-MS.

Recommended Books (Latest Editions)


1. Instrumental Methods of Chemical Analysis by B.K Sharma
2. Organic spectroscopy by Y.R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors
4. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel
5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
6. Organic Chemistry by I. L. Finar
7. Organic spectroscopy by William Kemp
8. Quantitative Analysis of Drugs by D. C. Garrett
9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
10. Spectrophotometric identification of Organic Compounds by Silverstein

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

BP 812 ET. DIETARY SUPPLEMENTS AND NUTRACEUTICALS

No. of hours :3 Tutorial:1 Credit point:4

Scope :

This subject covers foundational topic that are important for understanding the need and
requirements of dietary supplements among different groups in the population.

Objective:

This module aims to provide an understanding of the concepts behind the theoretical
applications of dietary supplements. By the end of the course, students should be able to :

1. Understand the need of supplements by the different group of people to maintain


healthy life.
2. Understand the outcome of deficiencies in dietary supplements.
3. Appreciate the components in dietary supplements and the application.
4. Appreciate the regulatory and commercial aspects of dietary supplements including
health claims.
UNIT I 07 hours

a. Definitions of Functional foods, Nutraceuticals and Dietary supplements. Classification


of Nutraceuticals, Health problems and diseases that can be prevented or cured by
Nutraceuticals i.e. weight control, diabetes, cancer, heart disease, stress, osteoarthritis,
hypertension etc.
b. Public health nutrition, maternal and child nutrition, nutrition and ageing, nutrition
education in community.
c. Source, Name of marker compounds and their chemical nature, Medicinal uses and health
benefits of following used as nutraceuticals/functional foods: Spirulina, Soyabean,
Ginseng, Garlic, Broccoli, Gingko, Flaxseeds
UNIT II 15 hours

Phytochemicals as nutraceuticals: Occurrence and characteristic features(chemical nature


medicinal benefits) of following

a) Carotenoids- α and β-Carotene, Lycopene, Xanthophylls, leutin


b) Sulfides: Diallyl sulfides, Allyl trisulfide.
c) Polyphenolics: Reservetrol
d) Flavonoids- Rutin , Naringin, Quercitin, Anthocyanidins, catechins, Flavones
e) Prebiotics / Probiotics.: Fructo oligosaccharides, Lacto bacillum

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

f) Phyto estrogens : Isoflavones, daidzein, Geebustin, lignans


g) Tocopherols
h) Proteins, vitamins, minerals, cereal, vegetables and beverages as functional foods: oats,
wheat bran, rice bran, sea foods, coffee, tea and the like.
UNIT III 07 hours

a) Introduction to free radicals: Free radicals, reactive oxygen species, production of free
radicals in cells, damaging reactions of free radicals on lipids, proteins, Carbohydrates,
nucleic acids.
b) Dietary fibres and complex carbohydrates as functional food ingredients..

UNIT IV 10 hours

a) Free radicals in Diabetes mellitus, Inflammation, Ischemic reperfusion injury, Cancer,


Atherosclerosis, Free radicals in brain metabolism and pathology, kidney damage,
muscle damage. Free radicals involvement in other disorders. Free radicals theory of
ageing.
b) Antioxidants: Endogenous antioxidants – enzymatic and nonenzymatic antioxidant
defence, Superoxide dismutase, catalase, Glutathione peroxidase, Glutathione Vitamin
C, Vitamin E, α- Lipoic acid, melatonin
Synthetic antioxidants: Butylated hydroxy Toluene, Butylated hydroxy Anisole.
c) Functional foods for chronic disease prevention
UNIT V 06 hours
a) Effect of processing, storage and interactions of various environmental factors on the
potential of nutraceuticals.
b) Regulatory Aspects; FSSAI, FDA, FPO, MPO, AGMARK. HACCP and GMPs on Food
Safety. Adulteration of foods.
c) Pharmacopoeial Specifications for dietary supplements and nutraceuticals.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

References:
1. Dietetics by Sri Lakshmi
2. Role of dietary fibres and neutraceuticals in preventing diseases by K.T Agusti and
[Link]: BSPunblication.
3. Advanced Nutritional Therapies by Cooper. K.A., (1996).
4. The Food Pharmacy by Jean Carper, Simon & Schuster, UK Ltd., (1988).
5. Prescription for Nutritional Healing by James [Link] and Phyllis [Link] 2nd Edn.,
Avery Publishing Group, NY (1997).
6. G. Gibson and [Link] Editors 2000 Functional foods Woodhead [Link].
7. Goldberg, I. Functional Foods. 1994. Chapman and Hall, New York.
8. Labuza, T.P. 2000 Functional Foods and Dietary Supplements: Safety, Good
Manufacturing Practice (GMPs) and Shelf Life Testing in Essentials of Functional Foods
M.K. Sachmidl and T.P. Labuza eds. Aspen Press.
9. Handbook of Nutraceuticals and Functional Foods, Third Edition (Modern Nutrition)
10. Shils, ME, Olson, JA, Shike, M. 1994 Modern Nutrition in Health and Disease. Eighth
edition. Lea and Febiger

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Semester VIII – Elective course on Pharmaceutical Product Development


No of Hours : 3 Tutorial : 1 Credit points : 4
Unit-I 10 Hours
Introduction to pharmaceutical product development, objectives, regulations related to
preformulation, formulation development, stability assessment, manufacturing and quality
control testing of different types of dosage forms

Unit-II 10 Hours
An advanced study of Pharmaceutical Excipients in pharmaceutical product development
with a special reference to the following categories
i. Solvents and solubilizers
ii. Cyclodextrins and their applications
iii. Non - ionic surfactants and their applications
iv. Polyethylene glycols and sorbitols
v. Suspending and emulsifying agents
vi. Semi solid excipients

Unit-III 10 Hours
An advanced study of Pharmaceutical Excipients in pharmaceutical product development
with a special reference to the following categories
i. Tablet and capsule excipients
ii. Directly compressible vehicles
iii. Coat materials
iv. Excipients in parenteral and aerosols products
v. Excipients for formulation of NDDS
Selection and application of excipients in pharmaceutical formulations with specific
industrial applications

Unit-IV 08 Hours
Optimization techniques in pharmaceutical product development.A study of various
optimization techniques for pharmaceutical product development with specific
[Link] by factorial designs and their applications.A study of QbD and its
application in pharmaceutical product development.

Unit-V 07 Hours
Selection and quality control testing of packaging materials for pharmaceutical product
development- regulatory considerations.

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Recommended Books (Latest editions)


1. Pharmaceutical Statistics Practical and Clinical Applications by Stanford Bolton,
CharlesBon; Marcel Dekker Inc.
2. Encyclopedia of Pharmaceutical Technology, edited by James swarbrick, Third
Edition,Informa Healthcare publishers.
3. Pharmaceutical Dosage Forms, Tablets, Volume II, edited by Herbert A. Lieberman
andLeon Lachman; Marcel Dekker, Inc.
4. The Theory and Practice of Industrial Pharmacy, Fourth Edition, edited by Roop
kKhar, S P Vyas, Farhan J Ahmad, Gaurav K Jain; CBS Publishers and Distributors
[Link]. 2013.
5. Martin’s Physical Pharmacy and Pharmaceutical Sciences, Fifth Edition, edited by
Patrick J. Sinko, BI Publications Pvt. Ltd.
6. Targeted and Controlled Drug Delivery, Novel Carrier Systems by S. P. Vyas and
R. [Link], CBS Publishers and Distributors Pvt. Ltd, First Edition 2012.
7. Pharmaceutical Dosage Forms and Drug Delivery Systems, Loyd V. Allen Jr.,
Nicholas [Link], Howard C. Ansel, 9th Ed. 40
8. Aulton’s Pharmaceutics – The Design and Manufacture of Medicines, Michael E.
Aulton,3rd Ed.
9. Remington – The Science and Practice of Pharmacy, 20th Ed.
10. Pharmaceutical Dosage Forms – Tablets Vol 1 to 3, A. Liberman, Leon Lachman
andJoseph B. Schwartz
11. Pharmaceutical Dosage Forms – Disperse Systems Vol 1 to 3, H.A. Liberman,
Martin, M.R and Gilbert S. Banker.
12. Pharmaceutical Dosage Forms – Parenteral Medication Vol 1 & 2, Kenneth E. Avis
andH.A. Libermann.
13. Advanced Review Articles related to the topics.
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Recommended for Non credit Pharmacy Add On courses for B. Pharm Program

The Member of BOS recommended draft proposal Non Credit Pharmacy add on Courses for
3rd Semester to 6th semester for B. Pharm Students at University Level

1. Noncredit Add on courses can be conducted in affiliated college of VMSBUTU.


Student can select audit course from mentioned courses of university 2nd year onwards
(i.e-3rd semester to 6th Semester). This course duration will be of Six Months.

2. In six months (At least 02 hrs /Week) Training & Learning Process in Industries
/College Laboratory. After completion of Syllabus Student will submit a report in college.
University will conduct Theory and Practical Examination of 50 Marks for each. For Practical
Examination University can appoint an external examiner for the evaluation of Project Work.

Than University can Award an Add- on Course completion certificate after students secured
minimum passing marks.

Semester Course Name of the course No of Max Minimum


Code Theory/Practical Marks Marks
Hrs Per week T/P T./P
3rd Sem AD 301 Basic Computer Skills 02 hrs. 50 25

4th Sem AD 401 Human Values and 02 hrs 50 25


Professional Ethics
5th Sem AD 501 Hands on Training on 02 hrs 50 25
Analytical Instruments
6th Sem AD 601 Communication Skill 02 hrs 50 25
and Personality
Development
*T-Theory-Max 50 Marks *P-Practical –Max 50 marks
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

SYLLABUS FOR ADD ON COURSES

Semester 3rd
Program Pharmacy
Course Code AD 301 Credit NC

Subject BASIC COMPUTER SKILLS Duration 36 Hours

Objectives of the Course:


The course is designed to aim at imparting a basic level appreciation programme for the
Common man. After completing the course, the incumbent is able to the use the computer for
basic purposes of preparing his personnel/business letters, viewing information on Internet
(the Web), sending mails, using internet banking services etc.
Module-I (Total Hours-8)
Understanding Word Processing: Word Processing Basics; Opening and Closing of documents; Text
creation and Manipulation; Formatting of text; Table handling; Spell check, language setting and
thesaurus; Printing of word document.

Module-II (Total Hours-6)


Using Spread Sheet: Basics of Spreadsheet; Manipulation of cells; Formulas and Functions; Editingof
Spread Sheet, printing of Spread Sheet.

Module-III (Total Hours-8)


Making Small Presentation: Basics of presentation software; Creating Presentation; Preparation and
Presentation of Slides; Slide Show; Taking printouts of presentation / handouts.

Module-IV (Total Hours-8)


Communications and collaboration: Basics of electronic mail; Getting an email account; Sending and
receiving emails; Accessing sent emails; Using Emails; Document collaboration; Instant Messaging;
Netiquettes.

Course Outcomes (COs):


AD 301-CO1: Demonstrate a basic understanding of computer
AD301-CO2: Utilize web technologies.
AD 301-CO3: Demonstrate basic understanding of network principles
AD 301-CO4: Apply the skills that are the focus of this program to business scenarios.
References:
1. Computer Fundamentals, 1st Edition, 2017, RS Salaria, Khanna Publishing House
2. Fundamentals of Computers, 6th Edition, V. Rajaraman, NeeharikaAdabala, PHI Learning
Private Ltd.
3. Microsoft office Access - 2003, Application Development Using VBA, SQL Server, DAP and
Infopath – Cary [Link] – Wiley Dreamtech India (P) Ltd., 4435/7, Ansari Road,
Daryagani, New Delhi – 110002
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Semester 4th
Program Pharmacy
Course Code AD 401 Credit NC

Subject HUMAN VALUES AND Duration 36 Hours


PROFESSIONAL ETHICS
Objectives of the Course:
Promotion of Ethics and Human Values are as under:
To create awareness, conviction & commitment to values for improving the quality of life through
education, and for advancing social and human well being.
Module-I (Total Hours-6)
Introduction –Need, Basic Guidelines and Content

Understanding the need, basic guidelines, content and process for value Education
Self Exploration – What is it? – its content and process: ‘Natural Acceptance’ and Experiential Validation –as
the mechanism for self explanation
Continuous Happiness and Prosperity – A look at basic Human Aspirations
Module-II (Total Hours-6)
Process for Value Education

Right Understanding, Relationship and Physical Facilities – basic requirements for fulfillment of aspirationsof
every human being with their correct priority
Understanding Happiness and prosperity correctly – A critical appraisal of the current scenario Method
to fulfill the above human aspirations; understanding and living in harmony at various levels

Module-III (Total Hours-8)


Understanding Harmony in the Human Being
Understanding human being as a co-existence of the sentient ‘I’ and the material ‘Body’
Understanding the needs of Self ( ‘I’ ) and ‘Body’ – Sukh and Suvidha
Understanding the Body as an instrument of ‘I’ (I being the doer, seer and enjoyer)
Module-IV (Total Hours-8)
Harmony in Myself
Understanding the characteristics and activities of ‘I’ and harmony in ’I’
Understanding the harmony of I with the Body: Sanyam and Swasthya: correct appraisal of Physical needs,
meaning of Prosperity in detail
Programs to ensure Sanyam and Swasthya – practice exercises and Case Studies will be taken up in Practice
Sessions
Module-V (Total Hours-8)
Understanding Harmony in the Family and Society – harmony in Human - Human Relationship
Understanding harmony in the family – the basic unit of human interaction
Understanding values in human relationship; meaning of Nyaya and Program for its fulfillment to ensure
Ubhay-tripti Trust (Vishwas) and Respect (Samman) as the foundational values of relationship.
Course Outcomes (COs):
AD401-CO1: Understand the need, basic guidelines, content and process for value Education
AD401-CO2: Identify Happiness and prosperity correctly, Method to fulfill the above human
aspirations.
AD 401-CO3: Assess the human being as a co-existence of the sentient ‘I’ and the material Body’.
AD-401-CO4: Evaluate the characteristics and activities of ‘I’ and harmony in ’I’.
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Reference:
1. Professional Ethics and Human Values-2013, Govindarajan M, PHI Learning Private Ltd.
2. A Foundation Course in Human Values and Professional Ethics-2010, Gaur R.R., Sangal R., Rupa
Publication, India

Syllabus of [Link]
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Semester 5th
Program Pharmacy
Course Code AD501 Credit NC

Subject Hands on training on Analytical Duration 36 Hours


Instruments
Objectives of the Course:
At the end of the course, students should be able to apply their knowledge of the theoretical
underpinnings and practical applications of contemporary instruments used in chemical
analysis to the analysis of actual samples.
Course contents/Curriculum (Total Hours-6 for each Instrument)

1. Overview of Instrumental Analysis and Measurements

Introduction, theory, principle, instrumentation concepts, applications, and calibration and


validation of instruments (any six out of the following);

[Link]-Visible spectrophotometer
[Link]
[Link] Photometer
[Link]
[Link]
[Link]
[Link]
[Link] Performance Liquid Chromatography
[Link] meter
[Link] viscometer
[Link] apparatus
Course Outcomes (COs):
AD501 CO1: Describe the various types of instrumental techniques used in chemistry.
AD501 CO2: Understand the theoretical basis of instruments.
AD501 CO3: Identify the components and uses of various parts of instruments.
AD501 CO4: Understand the calibration of various analytical instruments.
AD501 CO5: To evaluate and statistically analyse the data gathered using various
instrumental techniques.
AD501CO6: Interpret the results of the chemical analysis.
References:

[Link] Methods of Chemical Analysis by B.K Sharma


[Link] spectroscopy by William Kemp
3. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel
4. Spectrophotometric identification of Organic Compounds by Silverstein
5. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
6. Martin's Physical Pharmacy and Pharmaceutical Sciences
7. Fundamentals of analytical chemistry by Skoog, Douglas A.; West, Donald M.
8. Modern analytical chemistry by Harvey D.
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Semester 6th
Program Pharmacy
Course Code AD601 Credit NC

Course Name LEADERSHIP Duration 36 Hours


SKILLS
Objectives of the Course:

1. Students to develop essential skills to influence and motivate others


2. Inculcate emotional and social intelligence and integrative thinking for effective leadership
3. Create and maintain an effective and motivated team to work for the society
4. Nurture a creative and entrepreneurial mindset

Module I (Total Hours-06)


Understanding Leadership: Defining Leadership; Global Leadership Attributes; Practicing
Leadership.
Module II (Total Hours-06)
Recognizing Your Traits: Historical Leaders; What Traits Do These Leaders Display? Leadership
Studies: What Traits Do Effective Leaders Exhibit.
Module III (Total Hours-06)
Engaging People’s Strength: Explore how strengths can make one a better leader. Understand the
concept of strength; Describe the historical background of strengths based leadership. Examine how to
identify strengths; Review measures used to assess strengths; Examine strengths based leadership
in practice.
Module IV (Total Hours-06)
Philosophy and Styles: Leadership Explained Theory X and Theory Y; Leadership Styles Explained;
Leadership Styles in Practice
Module V (Total Hours-06)
Attending to Tasks and Relationships: Task and Relationship Styles Explained; Task and
Relationship Styles in Practice.
Module VI (Total Hours-06)
Developing Leadership Skill: Understanding administrative skills and their use in practice.
Understanding interpersonal skills and their use in practice. Understanding conceptual skills and
their use in practice.
Course Outcomes (COs):
AD601 CO1: Build a strong foundation to grow managerial career.
AD601 CO2:Acquire core Leadership Competencies
AD601 CO3: Develop essential skills to influence and motivate others.
AD601 CO4: Ability to create and maintain an effective and motivated team to work for society.
VEER MADHO SINGH BHANDARI UTTARAKHAND TECHNICALUNIVERSITY, DEHRADUN

Reference:
1. Leadership And Team Building (2010), Uday Kumar Haldar, Oxford University Press
2. Leadership and Management Development, Dalton Kevin, Pearson.

Syllabus of [Link]

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